FDA.reportPublic FDA data

Metronidazole

Product NDC
33261-786
11-digit product format
332610786
Labeler code
33261
Product ID
33261-786_fe04d17d-f5c0-4dc3-b61c-8b8a0c88f0d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
GEL
Route
VAGINAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA020208
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2007-03-31
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
8 mg/g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-786IInactivated by FDA2026-08-03
excluded packagepackage33261-78633261-786-01IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020208-001METROGEL-VAGINALMETRONIDAZOLE0.75%GEL / VAGINALRLD1992-08-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020208-001METROGEL-VAGINAL0.75%GEL / VAGINALRLD1992-08-17a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEA-S Medication Solutions8b2c294b-ed70-447c-bbc4-2a8b59f1aca42023-10-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 020208
application number: NDA020208

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55Product name520251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17Product name120250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1Product name520250515
e1aac33b-94ae-4ee9-905b-299f7263853bProduct name320250124
16642716-d28a-4f90-8dcb-3921cd8c8109Product name420240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-786-012020-01-31C16284748780-19d75b9d0-fa30-f424-e053-dadaa90a57ceMetronidazole Vaginal Gel, 0.75%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-786-01Metronidazole70 g in 1 TUBE, WITH APPLICATORGEL701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-786-01GM - Gram33261-786d4d6bd85-c60c-4a69-b7fc-fde2db22904812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE GEL [AIDAREX PHARMACEUTICALS LLC]1
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE GEL [AIDAREX PHARMACEUTICALS LLC]1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208METRONIDAZOLE GEL [AIDAREX PHARMACEUTICALS LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMETRONIDAZOLE GEL [AIDAREX PHARMACEUTICALS LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMETRONIDAZOLE GEL [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METRONIDAZOLE GEL [AIDAREX PHARMACEUTICALS LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMETRONIDAZOLE GEL [AIDAREX PHARMACEUTICALS LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETRONIDAZOLE GEL [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-786METRONIDAZOLE GEL [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140128_5affa689-a7dc-4e1a-8405-4e15b6e9fff2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142046metroNIDAZOLE 0.75 % Vaginal GelPSN5affa689-a7dc-4e1a-8405-4e15b6e9fff21
142046metronidazole 0.0075 MG/MG Vaginal GelSCD5affa689-a7dc-4e1a-8405-4e15b6e9fff21
142046metronidazole 0.75 % Vaginal GelSY5affa689-a7dc-4e1a-8405-4e15b6e9fff21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-786-013326107860170 g in 1 TUBE, WITH APPLICATOR70 gHistorical