Home NDC 0299-3820-03 METROGEL
Product NDC 0299-3820
Requested package NDC 0299-3820-03
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 Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 2 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0299-3820 0299-3820-03 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0299-3820 0299-3820-03 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021789-001 METROGEL 1% GEL / TOPICAL AB RLD, RS 2005-06-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021789-001 6881726 2022-02-21 U-743 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021789-001 7348317 2022-02-21 U-743 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021789-001 6881726 2022-02-21 U-743 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021789-001 7348317 2022-02-21 U-743 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021789-001 6881726 2022-02-21 U-743 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021789-001 7348317 2022-02-21 U-743 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021789-001 6881726 2022-02-21 U-743 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021789-001 7348317 2022-02-21 U-743 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021789-001 6881726 2022-02-21 U-743 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021789-001 7348317 2022-02-21 U-743 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021789-001 6881726 2022-02-21 U-743 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021789-001 7348317 2022-02-21 U-743 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021789-001 6881726 2022-02-21 U-743 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021789-001 7348317 2022-02-21 U-743 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021789-001 6881726 2022-02-21 U-743 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021789-001 7348317 2022-02-21 U-743 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021789-001 6881726 2022-02-21 U-743 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021789-001 7348317 2022-02-21 U-743 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021789-001 6881726 2022-02-21 U-743 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021789-001 7348317 2022-02-21 U-743 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021789-001 6881726 2022-02-21 U-743 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021789-001 7348317 2022-02-21 U-743 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021789-001 6881726 2022-02-21 U-743 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021789-001 7348317 2022-02-21 U-743 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021789-001 6881726 2022-02-21 U-743 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021789-001 7348317 2022-02-21 U-743 Drug product ea99ee380514…2023-01-26 05:58 UTC 2023-01 N021789-001 6881726 2022-02-21 U-743 Drug product 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021789-001 7348317 2022-02-21 U-743 Drug product 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021789-001 6881726 2022-02-21 U-743 Drug product 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021789-001 7348317 2022-02-21 U-743 Drug product 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021789-001 6881726 2022-02-21 U-743 Drug product f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021789-001 7348317 2022-02-21 U-743 Drug product f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021789-001 6881726 2022-02-21 U-743 Drug product e64feba35796…2022-09-29 23:25 UTC 2022-09 N021789-001 7348317 2022-02-21 U-743 Drug product e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021789-001 6881726 2022-02-21 U-743 Drug product cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021789-001 7348317 2022-02-21 U-743 Drug product cb3db0bc1861…
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 0299-3820-03 00299382003 3 g in 1 TUBE (0299-3820-03) 3 g 2005-06-30 0000-00-00 No No Current