Is Dabur India Limited FDA approved?

Dabur India Limited holds 2 FDA-registered establishments in India. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Dabur India Limited's drugs manufactured?

The FDA register lists Silvassa; Solan. Registered operations: labelling, finished drug manufacture, packaging.

What drugs does Dabur India Limited make?

15 products are listed under Dabur India Limited in the openFDA NDC Directory, most often as gel, dentifrice; ointment; cream. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Dabur India Limited

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 15
Labeller names: 3
Live patents: 0
Countries: 1
Base: India

Authorisation

Registered operations

Labelling2Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Dabur India Limited	Survey No 225- 4 -1, Saily Village, Silvassa, 396240, India (IND)	Labelling, Finished drug manufacture, Packaging	3001413302650599231
Dabur India Limited	-greenfield unit, Greenfield Unit Tehsil-baddi, Manakpur, Solan, Himachal Pradesh 174101, India (IND)	Labelling, Finished drug manufacture, Packaging	3046619098930130941

Catalogue

Drug listings by form and route

15 active NDC listings: 15 human otc drug. By marketing category: OTC MONOGRAPH DRUG 15.

Dosage form	NDCs
gel, dentifrice	7
ointment	5
cream	2
gel	1

Route	NDCs
topical	8
dental	7

Labeller name on the listing	NDCs
dabur india limited	13
dabur india limited	1
dabur india ltd	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Chest Rub	Camphor (synthetic), Eucalyptus oil, and Menthol	ointment, topical	68747-3022OTC MONOGRAPH DRUG
Clotrimazole 1%	Clotrimazole	cream, topical	68747-3024OTC MONOGRAPH DRUG
Cold Ice Analgesic Gel	Menthol	gel, topical	68747-3021OTC MONOGRAPH DRUG
DABUR Vitamin A and D	White Petrolatum	ointment, topical	68747-3045OTC MONOGRAPH DRUG
DABUR ZINC OXIDE 3.8%	ZINC OXIDE	ointment, topical	68747-8020OTC MONOGRAPH DRUG
Freshen Up	SODIUM FLUORIDE	gel, dentifrice, dental	87846-007OTC MONOGRAPH DRUG
Freshen Up Holiday mint	SODIUM FLUORIDE	gel, dentifrice, dental	87846-001OTC MONOGRAPH DRUG
Freshen Up Vanilla Mint	SODIUM FLUORIDE	gel, dentifrice, dental	87846-006OTC MONOGRAPH DRUG
Freshen Up chai latte mint	SODIUM FLUORIDE	gel, dentifrice, dental	87846-005OTC MONOGRAPH DRUG
Freshen Up pepper mint	SODIUM FLUORIDE	gel, dentifrice, dental	87846-002OTC MONOGRAPH DRUG
Freshen Up twisted peppermint	SODIUM FLUORIDE	gel, dentifrice, dental	87846-004OTC MONOGRAPH DRUG
Freshen-up Matcha Mint	SODIUM FLUORIDE	gel, dentifrice, dental	87846-003OTC MONOGRAPH DRUG
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHED	ZINC OXIDE	cream, topical	68747-6082OTC MONOGRAPH DRUG
dabur	Zinc Oxide	ointment, topical	68747-3040OTC MONOGRAPH DRUG
dabur First Aid	Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate	ointment, topical	68747-3025OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Morepen Laboratories LimitedSolan, IND · 2 sites
Immacule Lifesciences Private LimitedSolan, IND · 2 sites
Zydus Lifesciences LimitedSolan, IND
Glenmark Pharmaceuticals Inc., USASolan, IND
Ipca Laboratories LimitedSilvassa, IND
FDC LimitedSolan, IND
Ceph Lifesciences Private LimitedSolan, IND
SENTISS PHARMA PRIVATE LIMITEDSolan, IND
ALLIANCE FORMULATIONSSolan, IND
KusuMa PharMaSilvassa, IND
MDC PHARMACEUTICALS LIMITEDSolan, IND
PANACEA BIOTEC PHARMA LIMITEDSolan, IND

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Enquiry

Common questions

Is Dabur India Limited FDA approved?: Dabur India Limited holds 2 FDA-registered establishments in India. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Dabur India Limited's drugs manufactured?: The FDA register lists Silvassa; Solan. Registered operations: labelling, finished drug manufacture, packaging.
What drugs does Dabur India Limited make?: 15 products are listed under Dabur India Limited in the openFDA NDC Directory, most often as gel, dentifrice; ointment; cream. 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.