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 82 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blue Lizard Baby SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d6e04a-fa30-ba48-e063-6394a90a1bbf2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f780daa-4c91-5a68-e063-6394a90afd412026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50ZINC OXIDECrown Laboratories99839894-9695-2cd1-e053-2995a90acba62026-01-12WarningsExact identifier
application number: M020
Blue Lizard SPF 15 Lip BalmZINC OXIDECrown Laboratories1bf8fb7e-9d5b-86d4-e063-6294a90afddc2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50ZINC OXIDECrown Laboratories9983563c-1e63-0748-e053-2a95a90a971e2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Baby SPF 50ZINC OXIDECrown Laboratories9948f5b8-43bd-1c99-e053-2a95a90a61212026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer SPF 50 SunscreenZINC OXIDECrown Laboratories3368f1cb-c341-e886-e063-6394a90a9b7c2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f3844d8-0367-aad9-e063-6294a90a1fce2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer Face SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories30cd79da-2f25-a42a-e063-6394a90a83322026-01-12WarningsExact identifier
application number: M020
ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREENTITAMIUN DIOXIDE, ZINC OXIDEUCL Co., Ltd.4837b4f6-ada9-801a-e063-6294a90a85472026-01-12WarningsExact identifier
application number: M020
Intellishade Original SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213a681-eb22-69c0-e053-2995a90a899e2026-01-12WarningsExact identifier
application number: M020
GINZING SPF 40 ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 SHEER TINT RELEASEHOMOSALATE,OCTINOXATE,OCTISALATE, AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.48393640-4b97-04de-e063-6294a90aa6a62026-01-12WarningsExact identifier
application number: M020
Hale and Hush Broad Spectrum SPF 30 SPF 30ZINC OXIDEEclectic Solutions LLC0530904f-b02c-d8cf-e063-6294a90aa5a72026-01-12WarningsExact identifier
application number: M020
Minori Daily Mineral Face Sunscreen Broad Spectrum SPF 30ZINC OXIDEMinori Inc.1d4e2654-1638-0d01-e063-6394a90af3032026-01-12WarningsExact identifier
application number: M020
LUXURY BODY RITUAL HYDRATING SPF 30ZINC OXIDEJANE STREET LLC15e9d688-f226-1a19-e063-6394a90ab9062026-01-12WarningsExact identifier
application number: M020
BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD0426b1e9-063b-c1e6-e063-6294a90a25542026-01-11WarningsExact identifier
application number: M020
SPF30 MINERAL SUNSCREEN MOUSSEZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48031a0f-c2ed-5424-e063-6294a90ad0ff2026-01-10WarningsExact identifier
application number: M020
SPF 30 MINERAL WHIPPED CREAMS SHIMMERZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48037a05-722e-4231-e063-6294a90ac51f2026-01-10WarningsExact identifier
application number: M020
ODLUMIVIE Tinted Mineral SunscreenZINC OXIDE,TITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.480d6e65-f6dc-d2a5-e063-6294a90a24a12026-01-10WarningsExact identifier
application number: M020
Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFUTURE 8 LLC9922f132-f6a5-41ca-847a-936b20bf17162026-01-09WarningsExact 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