Home NDC 0299-3820-99 METROGEL
Product NDC 0299-3820
Requested package NDC 0299-3820-99
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# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0299-3820 0299-3820-99 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0299-3820 0299-3820-99 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0299-3820 0299-3820-99 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0299-3820 0299-3820-99 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0299-3820 0299-3820-99 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0299-3820 0299-3820-99 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0299-3820 0299-3820-99 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0299-3820 0299-3820-99 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0299-3820 0299-3820-99 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0299-3820 0299-3820-99 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0299-3820 0299-3820-99 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 0299-3820-99 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…
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 0299-3820-99 00299382099 55 g in 1 BOTTLE, PUMP (0299-3820-99) 55 g 2011-10-19 0000-00-00 No No Current