FDA.reportPublic FDA data

Johnsons Baby Care Essentials Gift Set

Product NDC
69968-0953
11-digit product format
699680953
Labeler code
69968
Product ID
69968-0953_43edc298-39da-5eb5-e063-6394a90a134e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
KIT
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
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
Johnsons Baby Care Essentials Gift Set
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094560Internal RxNorm lookup
1797059Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43edc287-57e1-d96e-e063-6294a90ac5a1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0848-9Johnsons Baby Care Essentials Gift Set1 in 1 CARTONPASTE400 mg in 1g1
69968-0848-9Johnsons Baby Care Essentials Gift Set28 g in 1 TUBEPASTE28 g400 mg in 1g1
69968-0953-9Johnsons Baby Care Essentials Gift Set1 in 1 PACKAGEKIT11

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 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EELHOE Cuticle Pusher PenGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.52c7f956-a2a1-ae1d-e063-6294a90ab3c22026-05-27WarningsExact identifier
application number: M016
Dermoia Eczema Relief Colloidal OatmealOATMEALTreasurewise LLC1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a2026-05-27WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWal-Mart Stores, Inc.61e76e2a-fc46-7a64-e053-2991aa0a56a82026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEWal-Mart Stores, Inc.61929c97-bd6b-0d7c-e053-2991aa0aa5712026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
application number: M016
Humco CalamineCALAMINE 8% AND ZINC OXIDE 8%Humco holding Group, Inc.f7dcd959-fb98-43bb-8dd3-a662bf8a053c2026-05-26WarningsExact identifier
application number: M016
Advanced HealingPETROLATUMCVS Pharamacy, Inc0bd3380e-2284-44a7-b2ef-68c9909627fd2026-05-26Warnings, Adverse reactionsExact identifier
application number: M016
CeraVe Developed with Dermatologists Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
application number: M016
AFTER CAREDIMETHICONEMerz North Americac19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae2026-05-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA63b551fc-7d16-c099-e053-2a91aa0a5f2c2026-05-18WarningsExact identifier
application number: M016
ADVANCED SILICONE SCARALLANTOINYantai Aien Biotechnology Co., Ltd.51ffdc45-5acf-ae20-e063-6294a90a55e82026-05-17WarningsExact identifier
application number: M016
LCFateLC Nail LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.51ea23f4-0a23-4ae1-e063-6394a90aa0512026-05-16WarningsExact identifier
application number: M016
Radlive Active Defense Nano-Silver CreamCOLLOIDAL OATMEALSilverCeuticals51e23135-008d-9db5-e063-6294a90a7d612026-05-15WarningsExact identifier
application number: M016
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
application number: M016
Triple 3x Max Diaper RashZINC OXIDEAdvantice Health, LLCe554046b-cd0a-4a6e-8f24-2e610c6974322026-05-14WarningsExact identifier
application number: M016
Eczema TherapyCOLLOIDAL OATMEALSilverCeuticals3a26a35e-a098-0e22-e063-6294a90a96b92026-05-13WarningsExact identifier
application number: M016
Nail- PflasterGLYCERINShantou Ximonth Biotechnology Co., Ltd.519681bc-6312-f627-e063-6394a90a28452026-05-11WarningsExact identifier
application number: M016
HydratingPETROLATUMAldermed Inc.4aa6a354-e487-4b65-e063-6394a90abbf02026-05-09WarningsExact identifier
application number: M016
Diaper RashZINC OXIDEAldermed Inc.4aa79292-dc91-b538-e063-6294a90ac3f02026-05-09WarningsExact identifier
application number: M016
XIMONTH Nail Fungus Care LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.514a998d-aa2a-46b6-e063-6294a90a6c222026-05-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797059Desitin 40 % Topical PastePSN43edc287-57e1-d96e-e063-6294a90ac5a11
1094560zinc oxide 40 % Topical PastePSN43edc287-57e1-d96e-e063-6294a90ac5a11
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD43edc287-57e1-d96e-e063-6294a90ac5a11
1094560zinc oxide 0.4 MG/MG PasteSCD43edc287-57e1-d96e-e063-6294a90ac5a11
1797059Desitin 40 % Topical PasteSY43edc287-57e1-d96e-e063-6294a90ac5a11
1094560zinc oxide 40 % PasteSY43edc287-57e1-d96e-e063-6294a90ac5a11
1094560ZNO 0.4 MG/MG PasteSY43edc287-57e1-d96e-e063-6294a90ac5a11
1797059ZNO 0.4 MG/MG Paste [Desitin]SY43edc287-57e1-d96e-e063-6294a90ac5a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0848-9699680848091 in 1 CARTONHistorical
69968-0953-9699680953091 KIT in 1 PACKAGE (69968-0953-9) * 100 mL in 1 BOTTLE * 100 mL in 1 BOTTLE * 1 TUBE in 1 CARTON (69968-0848-9) / 28 g in 1 TUBE1 kit2025-12-01NoNoCurrent