Home NDC 51672-5318 Bebe Bottoms
Product NDC 51672-5318
11-digit product format 516725318
Labeler code 51672
Product ID 51672-5318_2c3d94e3-13cd-a55d-e063-6394a90a480b
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form SPRAY
Route TOPICAL
Labeler TARO PHARMACEUTICALS U.S.A., INC.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-01
Substance ZINC OXIDE
Active strength 100 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 · 6 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 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51672-5318-3 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51672-5318-7 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51672-5318-3 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51672-5318-7 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Bebe Bottoms
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1232104 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-5318-3 Bebe Bottoms 50 mL in 1 BOTTLE, SPRAY SPRAY 50 4 51672-5318-3 Bebe Bottoms 1 in 1 CARTON SPRAY 1 4 51672-5318-7 Bebe Bottoms 1 in 1 CARTON SPRAY 1 4 51672-5318-7 Bebe Bottoms 100 mL in 1 BOTTLE, SPRAY SPRAY 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-5318 BEBE BOTTOMS (ZINC OXIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.] 4 Current NDC, 4 package rows 20250123_eb8512db-f8a9-432c-8779-2971411ce43d.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 39 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 51672-5318-3 51672531803 1 BOTTLE, SPRAY in 1 CARTON (51672-5318-3) / 50 mL in 1 BOTTLE, SPRAY 2023-12-01 No No Current 51672-5318-7 51672531807 1 BOTTLE, SPRAY in 1 CARTON (51672-5318-7) / 100 mL in 1 BOTTLE, SPRAY 2023-12-01 No No Current