Is Advanced Rx LLC FDA approved?

Advanced Rx LLC holds no registered establishment of its own; 40 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Advanced Rx LLC make?

40 products are listed under Advanced Rx LLC in the openFDA NDC Directory, most often as tablet; capsule, liquid filled; capsule, gelatin coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Advanced Rx LLC

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 40
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

40 active NDC listings: 40 human otc drug. By marketing category: OTC MONOGRAPH DRUG 31, ANDA 8, UNAPPROVED DRUG OTHER 1.

Dosage form	NDCs
tablet	14
capsule, liquid filled	8
capsule, gelatin coated	4
liquid	3
tablet, delayed release	3
tablet, extended release	2
cream	1
patch	1
powder	1
tablet, chewable	1
tablet, coated	1
tablet, film coated	1

Route	NDCs
oral	37
topical	3

Labeller name on the listing	NDCs
advanced rx llc	40

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ANTI-DIARRHEAL	Loperamide HCl	tablet, oral	80513-375ANDA
Adult Low Dose Aspirin	Aspirin	tablet, delayed release, oral	80513-289OTC MONOGRAPH DRUG
Allergy Relief	Diphenhydramine HCl	tablet, oral	80513-722OTC MONOGRAPH DRUG
Anti-Diarrheal	Loperamide Hydrochloride	tablet, oral	80513-401ANDA
Antifungal	Miconazole Nitrate	powder, topical	80513-771OTC MONOGRAPH DRUG
Aspirin 81mg Enteric Coated	Aspirin	tablet, delayed release, oral	80513-287OTC MONOGRAPH DRUG
Cetirizine hydrochloride	Cetirizine hydrochloride	tablet, coated, oral	80513-731ANDA
Cough Relief	Dextromethorphan Hydrobromide	capsule, liquid filled, oral	80513-311OTC MONOGRAPH DRUG
DAYTIME COLD AND FLU RELIEF	Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride	capsule, liquid filled, oral	80513-303OTC MONOGRAPH DRUG
DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE	capsule, gelatin coated, oral	80513-301OTC MONOGRAPH DRUG
DOCUSATE SODIUM, EXTRA STRENGTH 250 MG	DOCUSATE SODIUM	capsule, gelatin coated, oral	80513-100OTC MONOGRAPH DRUG
DOCUSATE SODIUM, EXTRA STRENGTH 250 MG	DOCUSATE SODIUM	capsule, gelatin coated, oral	80513-101OTC MONOGRAPH DRUG
Extra Strength Headache Relief	Acetaminophen, Aspirin, and Caffeine	tablet, oral	80513-362OTC MONOGRAPH DRUG
Fexofenadine HCl	Fexofenadine HCl	tablet, film coated, oral	80513-506ANDA
GUAIFENESIN	GUAIFENESIN	tablet, extended release, oral	80513-413ANDA
Gas Relief	Simethicone	capsule, liquid filled, oral	80513-111OTC MONOGRAPH DRUG
Gas Relief	Simethicone	capsule, liquid filled, oral	80513-112OTC MONOGRAPH DRUG
Gas Relief	Simethicone	capsule, liquid filled, oral	80513-117OTC MONOGRAPH DRUG
Gas Relief Ultimate Strength Softgels	Simethicone	capsule, liquid filled, oral	80513-119OTC MONOGRAPH DRUG
Laxative	Bisacodyl	tablet, delayed release, oral	80513-409OTC MONOGRAPH DRUG
Loratadine	Loratadine	tablet, oral	80513-711ANDA
MECLIZINE	Meclizine HCl 12.5 mg	tablet, oral	80513-427OTC MONOGRAPH DRUG
MUCUS RELIEF DM	Guaifenesin, Dextromethorphan HBr	tablet, oral	80513-407OTC MONOGRAPH DRUG
Maximum Strength Urinary Pain Relief	Phenazopyridine Hydrochloride	tablet, oral	80513-517UNAPPROVED DRUG OTHER
Meclizine	Meclizine Hydrochloride	tablet, chewable, oral	80513-421OTC MONOGRAPH DRUG
Mucus Relief	Guaifenesin	tablet, extended release, oral	80513-403ANDA
Multi-Symptom Nighttime Cold and Flu Relief	Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr	capsule, liquid filled, oral	80513-316OTC MONOGRAPH DRUG
NIGHT TIME SLEEP-AID	Diphenhydramine HCl	tablet, oral	80513-383OTC MONOGRAPH DRUG
NIGHTTIME COLD AND FLU RELIEF	Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate	capsule, liquid filled, oral	80513-304OTC MONOGRAPH DRUG
NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	capsule, gelatin coated, oral	80513-302OTC MONOGRAPH DRUG
Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	tablet, oral	80513-789OTC MONOGRAPH DRUG
Night Time Sleep Aid	Doxylamine Succinate	tablet, oral	80513-371ANDA
PUREGEN LABS Maximum Strength Lidocaine	LIDOCAINE	cream, topical	80513-813OTC MONOGRAPH DRUG
PUREGEN LABS Pain Relief 4 Lidocaine	LIDOCAINE	patch, topical	80513-814OTC MONOGRAPH DRUG
Puregen Labs Acetaminophen	Acetaminophen	liquid, oral	80513-001OTC MONOGRAPH DRUG
Puregen Labs Allergy Relief	Diphenhydramine HCl	liquid, oral	80513-201OTC MONOGRAPH DRUG
PurgenLabs Acetaminophen	Actaminophen	liquid, oral	80513-230OTC MONOGRAPH DRUG
SENNA-S	Docusate Sodium and Sennosides	tablet, oral	80513-105OTC MONOGRAPH DRUG
Sodium Bicarbonate 10 GR (650 MG)	Sodium Bicarbonate	tablet, oral	80513-611OTC MONOGRAPH DRUG
Sodium Chloride Normal Salt	Sodium Chloride	tablet, oral	80513-608OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is Advanced Rx LLC FDA approved?: Advanced Rx LLC holds no registered establishment of its own; 40 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Advanced Rx LLC make?: 40 products are listed under Advanced Rx LLC in the openFDA NDC Directory, most often as tablet; capsule, liquid filled; capsule, gelatin coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.