Home NDC 0299-3836 MetroCream
Product NDC 0299-3836
11-digit product format 002993836
Labeler code 0299
Product ID 0299-3836_02c98a23-7923-4f37-b2e5-627e688f3e09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form CREAM
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA020531
Marketing category NDA
Marketing start 1995-09-20
Substance METRONIDAZOLE
Active strength 7.5 mg/g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 N020531-001 METROCREAM METRONIDAZOLE 0.75% CREAM / TOPICAL AB RLD 1995-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020531-001 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 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD 1995-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD 1995-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD 1995-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020531-001 METROCREAM 0.75% CREAM / TOPICAL AB RLD, RS 1995-09-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0299-3836-45 MetroCream 45 g in 1 TUBE CREAM 45 2 0299-3836-45 MetroCream 1 in 1 CARTON CREAM 1 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Metronidazole ACTIVE INGREDIENT 140QMO216E METROCREAM (METRONIDAZOLE) CREAM [GALDERMA LABORATORIES, L.P.] 1 Metronidazole ACTIVE MOIETY 140QMO216E METROCREAM (METRONIDAZOLE) CREAM [GALDERMA LABORATORIES, L.P.] 1 Benzyl Alcohol INACTIVE INGREDIENT LKG8494WBH METROCREAM (METRONIDAZOLE) CREAM [GALDERMA LABORATORIES, L.P.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX METROCREAM (METRONIDAZOLE) CREAM [GALDERMA LABORATORIES, L.P.] 1 Isopropyl Palmitate INACTIVE INGREDIENT 8CRQ2TH63M METROCREAM (METRONIDAZOLE) CREAM [GALDERMA LABORATORIES, L.P.] 1 Lactic Acid INACTIVE INGREDIENT 33X04XA5AT METROCREAM (METRONIDAZOLE) CREAM [GALDERMA LABORATORIES, L.P.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I METROCREAM (METRONIDAZOLE) CREAM [GALDERMA LABORATORIES, L.P.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R METROCREAM (METRONIDAZOLE) CREAM [GALDERMA LABORATORIES, L.P.] 1 Water INACTIVE INGREDIENT 059QF0KO0R METROCREAM (METRONIDAZOLE) CREAM [GALDERMA LABORATORIES, L.P.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-3836 METROCREAM (METRONIDAZOLE) CREAM [GALDERMA LABORATORIES, L.P.] 2 Current NDC, Legacy NDC, 2 package rows 20180705_43d5e570-f359-564d-9bb4-51784ad97b6f.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 · 2 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 0299-3836-45 00299383645 1 TUBE in 1 CARTON (0299-3836-45) / 45 g in 1 TUBE 1 tube 1995-09-20 0000-00-00 No No Current