Home NDC 0299-3820-01 METROGEL
Product NDC 0299-3820
Requested package NDC 0299-3820-01
11-digit product format 002993820
Labeler code 0299
Product ID 0299-3820_c61f8bdc-60b9-4292-a9de-d418c31e9ad7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form GEL
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA021789
Marketing category NDA
Marketing start 2005-06-30
Marketing end 2026-05-31
Substance METRONIDAZOLE
Active strength 10 mg/g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021789-001 METROGEL METRONIDAZOLE 1% GEL / TOPICAL AB RLD, RS 2005-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021789-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N021789-001 AB 1 a50c72e98297…
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.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.] 5 Metronidazole ACTIVE MOIETY 140QMO216E METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.] 5 betadex INACTIVE INGREDIENT JV039JZZ3A METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.] 5 edetate disodium INACTIVE INGREDIENT 7FLD91C86K METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.] 5 methylparaben INACTIVE INGREDIENT A2I8C7HI9T METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.] 5 niacinamide INACTIVE INGREDIENT 25X51I8RD4 METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.] 5 phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.] 5 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.] 5 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.] 5 water INACTIVE INGREDIENT 059QF0KO0R METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.] 5 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 Metronidazole ACTIVE MOIETY 140QMO216E METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 betadex INACTIVE INGREDIENT JV039JZZ3A METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 edetate disodium INACTIVE INGREDIENT 7FLD91C86K METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 niacinamide INACTIVE INGREDIENT 25X51I8RD4 METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R METROGEL (METRONIDAZOLE) GEL [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-3820 METROGEL (METRONIDAZOLE) GEL [GALDERMA LABORATORIES, L.P.] 11 Current NDC, Legacy NDC, 5 package rows 20240420_ab3a8a2d-714a-4beb-af8a-99bc3ac3ebbe.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0299-3820-01 00299382001 55 g in 1 BOTTLE, PUMP (0299-3820-01) 55 g 2011-10-19 0000-00-00 No No Current