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Product NDC 0299-3838
11-digit product format 002993838
Labeler code 0299
Product ID 0299-3838_986498be-52fe-47ba-a639-5267a03e98bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form LOTION
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA020901
Marketing category NDA
Marketing start 1998-11-24
Marketing end 0000-00-00
Substance METRONIDAZOLE
Active strength 8 mg/mL
Pharmacologic classes Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0299-3838-02 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0299-3838-02 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020901-001 METROLOTION METRONIDAZOLE 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020901-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Metronidazole ACTIVE INGREDIENT 140QMO216E METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Metronidazole ACTIVE MOIETY 140QMO216E METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Benzyl Alcohol INACTIVE INGREDIENT LKG8494WBH METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Carbomer Homopolymer Type A INACTIVE INGREDIENT F68VH75CJC METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Cyclomethicone INACTIVE INGREDIENT NMQ347994Z METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Lactic Acid INACTIVE INGREDIENT 33X04XA5AT METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Light Mineral Oil INACTIVE INGREDIENT N6K5787QVP METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Polyethylene Glycol 400 INACTIVE INGREDIENT B697894SGQ METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Polyoxyl 100 Stearate INACTIVE INGREDIENT YD01N1999R METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Potassium Sorbate INACTIVE INGREDIENT 1VPU26JZZ4 METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Steareth-21 INACTIVE INGREDIENT 53J3F32P58 METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1 Water INACTIVE INGREDIENT 059QF0KO0R METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-3838 METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.] 3 Legacy NDC 20180706_c4e07c26-245d-3e51-6a47-fccde22334d2.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0299-3838-02 00299383802 1 BOTTLE, PLASTIC in 1 CARTON (0299-3838-02) > 59 mL in 1 BOTTLE, PLASTIC 1998-11-24 0000-00-00 No No Current