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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4bd417ba-3d24-46e3-a771-3183824f0219	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

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 8 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zinc Oxide 20%	ZINC OXIDE	Trifecta Pharmaceuticals USA	8cbe9b1f-fec0-9579-e053-2995a90ac461	2026-06-22	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Walmart Inc.	e294a871-ae73-4a4f-89a3-9ebf0b4fd03a	2026-06-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash Cream	ZINC OXIDE	Foshan Desha Biotechnology Co., Ltd.	5487ad62-3d73-042e-e063-6394a90afe8c	2026-06-18	Warnings	Exact identifier application number: M016
Baby HealingOintment	PETROLATUM	Foshan Desha Biotechnology Co., Ltd.	5488b81a-e5fe-1452-e063-6394a90a2ae4	2026-06-18	Warnings	Exact identifier application number: M016
Baby Eczema Moisturizing Cream	COLLOIDAL OATMEAL	Foshan Desha Biotechnology Co., Ltd.	548a0c34-6aac-14f7-e063-6394a90ae652	2026-06-18	Warnings	Exact identifier application number: M016
Jell with Vitamin A D	LANOLIN, PETROLATUM	Jell Pharmaceuticals Pvt Ltd.	d976e5f0-1be5-d9c4-e053-2a95a90a44a4	2026-06-17	Warnings	Exact identifier application number: M016
Dove	ANTIBACTERIAL CARE BEAUTY BAR	Conopco d/b/a Unilever	547472cf-4902-584e-e063-6294a90a28ac	2026-06-17	Warnings	Exact identifier application number: M016
Dr Sosnowskis Chafing Hero Severe Chafing Balm	LANOLIN	Herstat (USA) Inc.	389041a8-7316-b38e-e063-6294a90a3e8e	2026-06-17	Warnings	Exact identifier application number: M016
Drs. Pharmacy Creamy Cocoa Butter Petroleum Jelly	WHITE PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	546749e3-70c5-10e8-e063-6294a90ad8c4	2026-06-16	Warnings	Exact identifier application number: M016
Drs. Pharmacy Creamy Petroleum Jelly	WHITE PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	54698388-f9e8-c470-e063-6394a90a783b	2026-06-16	Warnings	Exact identifier application number: M016
Medline	ZINC OXIDE	Medline Industries, LP	3c319953-04fc-87a8-e063-6294a90a5058	2026-06-15	Warnings	Exact identifier application number: M016
Calamine, Pramoxind HCl	CALAMINE, PRAMOXIND HCL	H E B	4a7a0b09-d9bc-e752-e063-6394a90a9f2c	2026-06-15	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine, Zinc Oxide	CALAMINE, ZINC OXIDE	H E B	4a79259e-64ac-d187-e063-6294a90a78db	2026-06-15	Warnings, Adverse reactions	Exact identifier application number: M016
HEALMUSZ HEALTHY FEET	UREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEET	Jiangxi Yudexi Pharmaceutical Co., LTD	4a34b6de-03ec-3be4-e063-6294a90afb52	2026-06-14	Warnings	Exact identifier application number: M016
PUVIDA SNOW BLEACH	NIACINAMIDE 15% SNOW BLEACH	Jiangxi Yudexi Pharmaceutical Co., LTD	4a48ebbd-7c80-1bce-e063-6294a90ab4ae	2026-06-14	Warnings	Exact identifier application number: M016
XIMONTH Foot Shoe Deodorizer	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	541d9ce9-62ad-847e-e063-6394a90a55e0	2026-06-13	Warnings	Exact identifier application number: M016
Skin Protectant with 33% Petrolatum Advance Moisturizing Cream	PETROLATUM	Aldermed Inc.	87413149-d39f-4f8a-b1c9-6de5eb37ff7e	2026-06-12	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE, WHITE PETROLATUM	Aldermed Inc.	54154a72-27ad-7bfa-e063-6394a90a4eca	2026-06-12	Warnings	Exact identifier application number: M016
Circletong Tag Wart Remover Patches	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	541b0fe9-f900-8191-e063-6394a90af321	2026-06-12	Warnings	Exact identifier application number: M016
Baby Butz	ZINC OXIDE	Olen Skin Care Corporation	e6be6b62-13a4-410d-b8ac-457b58fd23da	2026-06-10	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2003464	zinc oxide 14 % Topical Ointment	PSN	4bd417ba-3d24-46e3-a771-3183824f0219	3
2003464	zinc oxide 0.14 MG/MG Topical Ointment	SCD	4bd417ba-3d24-46e3-a771-3183824f0219	3
2003464	zinc oxide 14 % Topical Ointment	SY	4bd417ba-3d24-46e3-a771-3183824f0219	3
2003464	ZNO 0.14 MG/MG Topical Ointment	SY	4bd417ba-3d24-46e3-a771-3183824f0219	3

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