Home NDC 81638-171 EARLY MOMMY Baby Bum Butta
Product NDC 81638-171
11-digit product format 816380171
Labeler code 81638
Product ID 81638-171_2cc50ef5-5470-e413-e063-6394a90a34d7
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form OINTMENT
Route TOPICAL
Labeler TEKT TONE LABS LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-01
Substance ZINC OXIDE
Active strength 140 mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 · 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 2025-01-20 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 81638-171-00 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 81638-171-00 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 EARLY MOMMY Baby Bum Butta
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 140 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 2003464 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81638-171-00 EARLY MOMMY Baby Bum Butta 118 mL in 1 JAR OINTMENT 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81638-171 EARLY MOMMY BABY BUM BUTTA (ZINC OXIDE) OINTMENT [TEKT TONE LABS LLC] 3 Current NDC, Legacy NDC, 1 package rows 20250130_4bd417ba-3d24-46e3-a771-3183824f0219.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 58 of 68 · 1,346 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 81638-171-00 81638017100 118 mL in 1 JAR (81638-171-00) 118 ml 2021-03-01 0000-00-00 No No Current