Home NDC 0299-3838-02 MetroLotion
Product NDC 0299-3838
Requested package NDC 0299-3838-02
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 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 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.
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 N020901-001 METROLOTION 0.75% LOTION / TOPICAL AB RLD, RS 1998-11-24 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 N020901-001 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 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
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