FDA.reportPublic FDA data

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
IngredientStrength
ZINC OXIDE25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1125471Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
641465a1-0daf-1bb9-e053-2a91aa0ab25dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71630-549-60Baby Diaper Rash Cream60 g in 1 TUBECREAM606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71630-549BABY DIAPER RASH CREAM (ZINC OXIDE) CREAM [DOTERRA INTERNATIONAL, LLC]6Current NDC, Legacy NDC, 1 package rows20250130_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 8 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceile tint PROTECT tinted serum SPF 50 IvoryCEILE TINT PROTECT TINTED SERUM SPF 50 IVORYLE COSMETICS INC58547809-3480-1032-e063-6294a90a04c62026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium DeepCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEPLE COSMETICS INC58549160-3594-9056-e063-6394a90abf7d2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 DeepCEILE TINT PROTECT TINTED SERUM SPF 50 DEEPLE COSMETICS INC585498d4-b29c-9580-e063-6394a90adf1e2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 FairCEILE TINT PROTECT TINTED SERUM SPF 50 FAIRLE COSMETICS INC58545633-cb36-6611-e063-6394a90a1f072026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 LightCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHTLE COSMETICS INC5853ae6b-0eaf-e614-e063-6394a90ae91a2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light MediumCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUMLE COSMETICS INC585473c3-3ee9-7d84-e063-6394a90abd332026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 MediumCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUMLE COSMETICS INC58547b48-251a-10eb-e063-6294a90ac95c2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium TanCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TANLE COSMETICS INC58547e38-ae84-82ee-e063-6394a90a27d62026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 TanCEILE TINT PROTECT TINTED SERUM SPF 50 TANLE COSMETICS INC58548331-38cd-8668-e063-6394a90a33622026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium HoneyCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM HONEYLE COSMETICS INC5854861a-376d-8825-e063-6394a90a8aab2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 HoneyCEILE TINT PROTECT TINTED SERUM SPF 50 HONEYLE COSMETICS INC585488c5-fac5-212f-e063-6294a90a00ff2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium RichCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM RICHLE COSMETICS INC585488af-d14f-8d71-e063-6394a90ac4f02026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 RichCEILE TINT PROTECT TINTED SERUM SPF 50 RICHLE COSMETICS INC58548e6d-9c82-249c-e063-6294a90a11ad2026-08-05WarningsExact identifier
application number: M020
12 Days of Derm-Loved SkincareOCTINOXATE, ZINC OXIDE, OATMEAL, BENZOYL PEROXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENERodan & Fieldsa13f0275-5add-4464-88d4-ff98232743252026-08-03WarningsExact identifier
application number: M020
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
application number: M020
Manyo Air Light Moisturizing Sunscreen SPF 50ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENEManyo Factory Corp.86761577-a32c-41a2-a2e3-b339b14937012026-08-03WarningsExact identifier
application number: M020
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
application number: M020
AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30OCTISALATE, OCTOCRYLENE, AVOBENZONEAMBI Enterprises LLC99bbe9a2-bb57-4a33-b339-1649d4b319c82026-07-31WarningsExact identifier
application number: M020
AMBI Even and Clear Facial Moisturizer SPF-30AVOBENZONE, OCTISALATE, OCTOCRYLENEAMBI Enterprises LLC4701c0ba-4ceb-4d66-9f99-515ce33b46482026-07-31WarningsExact identifier
application number: M020
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
application number: M020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1125471zinc oxide 25 % Topical CreamPSN641465a1-0daf-1bb9-e053-2a91aa0ab25d6
1125471zinc oxide 250 MG/ML Topical CreamSCD641465a1-0daf-1bb9-e053-2a91aa0ab25d6
1125471zinc oxide 25 % Topical CreamSY641465a1-0daf-1bb9-e053-2a91aa0ab25d6
1125471ZNO 250 MG/ML Topical CreamSY641465a1-0daf-1bb9-e053-2a91aa0ab25d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71630-549-607163005496060 g in 1 TUBE (71630-549-60) 60 g2018-05-090000-00-00NoNoCurrent