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 42 of 68 · 1,346 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Firming Care Gel FIRMING CARE GEL Guangzhou Jiaan Cosmetics Co.,Ltd. 32cb8a71-81cd-cdbd-e063-6394a90ac07f 2025-04-15 Warnings Exact identifier application number: M016 Baby Mantra Diaper Cream ZINC OXIDE 10% Renu Laboratories, LLC 0427bbc9-f4c0-0eb6-e063-6294a90a7199 2025-04-14 Warnings Exact identifier application number: M016 Witch Hazel WITCH HAZEL TOP CARE (Topco Associates LLC) 23b592f7-3af3-45ef-897a-fe33ab518b6d 2025-04-14 Warnings Exact identifier application number: M016 Witch Hazel WITCH HAZEL Strategic Sourcing Services LLC ef3408db-de98-4a43-9215-f80fed14815c 2025-04-14 Warnings Exact identifier application number: M016 Petroleum Jelly PETROLATUM Walgreens 69bdd508-7c33-42c5-9a08-e56cf3eaebf3 2025-04-11 Warnings Exact identifier application number: M016 4% 10gTATTOO Numb Cream 4% LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 322daa32-a74e-1fee-e063-6294a90a37aa 2025-04-07 Warnings Exact identifier application number: M016 Aluroderm Scar ALLANTOIN Asclemed USA, Inc. 60656ca1-5218-4595-854e-19f1061def1e 2025-04-01 Warnings Exact identifier application number: M016 Dr. Maxs Diaper ZINC OXIDE Dr. Maxs LLC 31bfa962-5e3b-c5d2-e063-6294a90ac177 2025-04-01 Warnings Exact identifier application number: M016 Vaseline BABY HEALING JELLY Conopco Inc. d/b/a Unilever bca3176f-86fe-5969-e053-2995a90a2419 2025-03-31 Warnings Exact identifier application number: M016 4% TATTOO Numb Cream 4% LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 31646815-f591-c560-e063-6294a90ad11a 2025-03-28 Warnings Exact identifier application number: M016 Face Saver Gel SKIN PROTECTANT GEL Neat Feat Products Limited 31563dd7-9f58-80f6-e063-6294a90a5571 2025-03-27 Warnings Exact identifier application number: M016 Porphose COLLOIDAL OATMEAL TOPICAL SPRAY Porphose 315951e0-899f-c968-e063-6294a90abe61 2025-03-27 Warnings Exact identifier application number: M016 Petroleum Jelly WHITE PETROLATUM JELLY WALGREENS 1fc9eecd-fd25-827c-e063-6394a90a26a5 2025-03-26 Warnings Exact identifier application number: M016 Cocoa Butter Petroleum Jelly WHITE PETROLATUM JELLY WALGREENS 1fcc9626-6058-e9b3-e063-6394a90ab525 2025-03-26 Warnings Exact identifier application number: M016 Nicotine Patches NICOTINE PATCHES Zhejiang FTA Shengzuozhi Biotechnology Co., LTD 313b08e2-d764-96da-e063-6294a90ab705 2025-03-25 Warnings Exact identifier application number: M016 Eczema Cream ECZEMA CREAM Kyte Baby LLC 30c943aa-d9dc-5c16-e063-6294a90a3c58 2025-03-20 Warnings Exact identifier application number: M016 Koala Kubs Diaper Rash Cream DIAPER RASH CREAM Melaleuca, Inc. c6b3b0dd-22a8-16f7-e053-2a95a90a51ea 2025-03-20 Warnings Exact identifier application number: M016 Gold Bond Eczema Relief Medicated Skin Protectant Cream COLLOIDAL OATMEAL Chattem, Inc. 2b6b8342-878d-4588-8b24-6746d35d319d 2025-03-19 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 30b20bd5-3b4f-8cc7-e063-6394a90a9106 2025-03-19 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 30b2744d-fb59-f383-e063-6294a90abd2a 2025-03-19 Warnings Exact identifier application number: M016
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