Baby Diaper Rash Cream

Product NDC: 71630-549
11-digit product format: 716300549
Labeler code: 71630
Product ID: 71630-549_2ccb71b9-14a3-ffee-e063-6294a90a8285
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: doTERRA International, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-05-09
Substance: ZINC OXIDE
Active strength: 25 g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Baby Diaper Rash Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	25 g/100g

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
1125471	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
641465a1-0daf-1bb9-e053-2a91aa0ab25d	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-01-31	Baby Diaper Rash Cream
2022-01-28	Baby Diaper Rash Cream
2020-02-03	Baby Diaper Rash Cream
2020-01-31	Baby Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71630-549-60	Baby Diaper Rash Cream	60 g in 1 TUBE	CREAM	60		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71630-549	BABY DIAPER RASH CREAM (ZINC OXIDE) CREAM [DOTERRA INTERNATIONAL, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20250130_641465a1-0daf-1bb9-e053-2a91aa0ab25d.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 121 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Bio H Plus Daily Defense And Revitalize	ZINC OXIDE	BIOHEALTH PLUS LLC	3765331e-ad4b-5661-e063-6294a90a7c20	2025-12-15	Exact identifier application number: M020
Facial Mineral Fusion	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	35944621-e6fb-cd98-e063-6294a90aa641	2025-12-15	Exact identifier application number: M020
Face Love	ZINC OXIDE	CLARITY SKIN CARE STUDIO, INC.	35d043a7-7269-469f-e063-6294a90a1a4d	2025-12-15	Exact identifier application number: M020
Mineral Mousse	TITANIUM DIOXIDE, ZINC OXIDE	CLARITY SKIN CARE STUDIO, INC.	35d00778-3857-ce8f-e063-6394a90ab375	2025-12-15	Exact identifier application number: M020
Chem-Free Sunscreen Non-Tinted Formula	ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	3594d573-c680-62c9-e063-6294a90a4229	2025-12-15	Exact identifier application number: M020
Chem Free Sunscreen Tinted Formula	ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	35948531-37ef-1fce-e063-6294a90ae79b	2025-12-15	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	R. Sonia Batra, MD, Inc.	35933039-8beb-9f98-e063-6394a90a60bb	2025-12-15	Exact identifier application number: M020
Simply Protected Tinted Mineral Sunscreen	ZINC OXIDE	Healthy Skin & Body LLC	380416b9-180a-3904-e063-6294a90a7bee	2025-12-15	Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	R. Sonia Batra, MD, Inc.	3592edca-cab0-6c44-e063-6294a90a1727	2025-12-15	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Healthy Skin & Body LLC	38046e71-f171-7e96-e063-6294a90a1f0b	2025-12-15	Exact identifier application number: M020
Barrier Plus Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Healthy Skin & Body LLC	38038beb-d0f0-ced2-e063-6294a90ac423	2025-12-15	Exact identifier application number: M020
Extreme Protection Non Tinted	ZINC OXIDE	BIOHEALTH PLUS LLC	3764cbeb-55f5-4a9c-e063-6394a90a863d	2025-12-15	Exact identifier application number: M020
Happy Mineral Sunscreen Primer SPF	TITANIUM DIOXIDE, ZINC OXIDE	ACNE CLINIC LAS VEGAS BY JUSTINA	37d9c5f2-f414-6efa-e063-6294a90a927f	2025-12-15	Exact identifier application number: M020
Comfort Mineral Mousse Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BIOHEALTH PLUS LLC	3765dd17-ffbd-bcf4-e063-6394a90a2c2b	2025-12-15	Exact identifier application number: M020
Prime And Protect Dewy	ZINC OXIDE	Kalon Skin Studio, LLC	3593cefe-a08f-eb88-e063-6394a90aaff6	2025-12-15	Exact identifier application number: M020
Glow	ZINC OXIDE	GODDESSLYNNEBODYANDSKIN	37247365-33ee-563d-e063-6394a90a249e	2025-12-15	Exact identifier application number: M020
Prime And Protect Matte	TITANIUM DIOXIDE, ZINC OXIDE	Kalon Skin Studio, LLC	35939630-1166-1c70-e063-6294a90aac6b	2025-12-15	Exact identifier application number: M020
Non-Tinted 20% Zinc Mineral Sunscreen	ZINC OXIDE	BELLA MEDICAL SKIN CARE	36d9d83b-7da5-a006-e063-6394a90a9d84	2025-12-15	Exact identifier application number: M020
Non-Tinted 20% Zinc Mineral Sunscreen	ZINC OXIDE	BELLA MEDICAL SKIN CARE	36da1a55-c076-cdd9-e063-6294a90ac97c	2025-12-15	Exact identifier application number: M020
Tinted Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	Goldberg, Howard S MD Inc	3598205d-2e87-9292-e063-6294a90a1f2a	2025-12-15	Exact identifier application number: M020

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
1125471	zinc oxide 25 % Topical Cream	PSN	641465a1-0daf-1bb9-e053-2a91aa0ab25d	6
1125471	zinc oxide 250 MG/ML Topical Cream	SCD	641465a1-0daf-1bb9-e053-2a91aa0ab25d	6
1125471	zinc oxide 25 % Topical Cream	SY	641465a1-0daf-1bb9-e053-2a91aa0ab25d	6
1125471	ZNO 250 MG/ML Topical Cream	SY	641465a1-0daf-1bb9-e053-2a91aa0ab25d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71630-549-60	71630054960	60 g in 1 TUBE (71630-549-60)	60 g	2018-05-09	0000-00-00	No	No	Current