FDA.reportPublic FDA data

Desitin Maximum Strength Zinc Oxide Diaper Rash

Product NDC
69968-0848
Requested package NDC
69968-0848-2
11-digit product format
699680848
Labeler code
69968
Product ID
69968-0848_2f357025-248d-8fe7-e063-6294a90ad14a
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
PASTE
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-14
Substance
ZINC OXIDE
Active strength
400 mg/g
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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-084869968-0848-2IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-084869968-0848-2IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…

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
Desitin Maximum Strength Zinc Oxide Diaper Rash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE400 mg/g

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 · 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
1590101a-c968-fca5-e063-6394a90a7cccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69968-0848-12024-11-25Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-22024-11-25Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-42024-11-25Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-52024-11-25Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-92024-11-25Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-12024-07-30Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-22024-07-30Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-42024-07-30Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-52024-07-30Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-92024-07-30Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0848-1Desitin Maximum Strength Zinc Oxide Diaper Rash454 g in 1 JARPASTE4545
69968-0848-2Desitin Maximum Strength Zinc Oxide Diaper Rash57 g in 1 TUBEPASTE575
69968-0848-2Desitin Maximum Strength Zinc Oxide Diaper Rash1 in 1 CARTONPASTE15
69968-0848-3Desitin Maximum Strength Zinc Oxide Diaper Rash3 in 1 CARTONPASTE35
69968-0848-3Desitin Maximum Strength Zinc Oxide Diaper Rash136 g in 1 TUBEPASTE1365
69968-0848-4Desitin Maximum Strength Zinc Oxide Diaper Rash1 in 1 CARTONPASTE15
69968-0848-4Desitin Maximum Strength Zinc Oxide Diaper Rash113 g in 1 TUBEPASTE1135
69968-0848-5Desitin Maximum Strength Zinc Oxide Diaper Rash1 in 1 CARTONPASTE15
69968-0848-5Desitin Maximum Strength Zinc Oxide Diaper Rash136 g in 1 TUBEPASTE1365
69968-0848-9Desitin Maximum Strength Zinc Oxide Diaper Rash28 g in 1 TUBEPASTE285
69968-0848-9Desitin Maximum Strength Zinc Oxide Diaper Rash1 in 1 CARTONPASTE15
69968-0848-9Johnsons Baby Care Essentials Gift Set28 g in 1 TUBEPASTE28 g400 mg in 1g3
69968-0848-9Johnsons Baby Care Essentials Gift Set1 in 1 CARTONPASTE400 mg in 1g3
69968-0848-2Johnsons First Touch Baby Gift Set1 in 1 CARTONPASTE400 mg in 1g1
69968-0848-2Gentle Care Kit57 g in 1 TUBEPASTE57 g400 mg in 1g1
69968-0848-2Johnsons First Touch Baby Gift Set57 g in 1 TUBEPASTE57 g400 mg in 1g1
69968-0848-2Gentle Care Kit1 in 1 CARTONPASTE400 mg in 1g1
69968-0848-2Johnsons Baby First Touch Gift Set57 g in 1 TUBEPASTE57 g400 mg in 1g1
69968-0848-2Johnsons Baby First Touch Gift Set1 in 1 CARTONPASTE400 mg in 1g1
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0848DESITIN MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH (ZINC OXIDE) PASTE [KENVUE BRANDS LLC]5Current NDC, 11 package rows20250303_1590101a-c968-fca5-e063-6394a90a7ccc.zip
69968-0848JOHNSONS BABY CARE ESSENTIALS GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]3Current NDC20250124_1ac59efd-9efd-09d9-e063-6394a90a5e40.zip
69968-0848JOHNSONS FIRST TOUCH BABY GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]1Current NDC20250124_2c2337cf-4507-7232-e063-6294a90a79c3.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 64 of 68 · 1,347 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact identifier
application number: M016
HEB CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d579680-6bcb-1161-e053-2991aa0aead12023-12-18WarningsExact identifier
application number: M016
Publix Clear Anti-ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6b905f-ed30-1ab7-e053-2a91aa0a816b2023-12-18WarningsExact identifier
application number: M016
Humco CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEHumco Holding Group, Inc.5fca3a73-6d66-496b-bd33-6e044f9039bc2023-12-15WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
application number: M016
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
application number: M016
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
application number: M016
Rite Aid CalamineCALAMINE 8% AND ZINC OXIDE 8%Rite Aid Corporation5df71189-9b36-9dee-e053-2a91aa0a9e492023-12-15WarningsExact identifier
application number: M016
GNP Witch HazelWITCH HAZELAmerisource Bergen45ac839d-215d-4c5f-8ae5-5e111d1700612023-12-14WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797059Desitin 40 % Topical PastePSN1590101a-c968-fca5-e063-6394a90a7ccc5
1094560zinc oxide 40 % Topical PastePSN1590101a-c968-fca5-e063-6394a90a7ccc5
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD1590101a-c968-fca5-e063-6394a90a7ccc5
1094560zinc oxide 0.4 MG/MG PasteSCD1590101a-c968-fca5-e063-6394a90a7ccc5
1797059Desitin 40 % Topical PasteSY1590101a-c968-fca5-e063-6394a90a7ccc5
1094560zinc oxide 40 % PasteSY1590101a-c968-fca5-e063-6394a90a7ccc5
1094560ZNO 0.4 MG/MG PasteSY1590101a-c968-fca5-e063-6394a90a7ccc5
1797059ZNO 0.4 MG/MG Paste [Desitin]SY1590101a-c968-fca5-e063-6394a90a7ccc5
1797059Desitin 40 % Topical PastePSN1ac59efd-9efd-09d9-e063-6394a90a5e403
1094560zinc oxide 40 % Topical PastePSN1ac59efd-9efd-09d9-e063-6394a90a5e403
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD1ac59efd-9efd-09d9-e063-6394a90a5e403
1094560zinc oxide 0.4 MG/MG PasteSCD1ac59efd-9efd-09d9-e063-6394a90a5e403
1797059Desitin 40 % Topical PasteSY1ac59efd-9efd-09d9-e063-6394a90a5e403
1094560zinc oxide 40 % PasteSY1ac59efd-9efd-09d9-e063-6394a90a5e403
1094560ZNO 0.4 MG/MG PasteSY1ac59efd-9efd-09d9-e063-6394a90a5e403
1797059ZNO 0.4 MG/MG Paste [Desitin]SY1ac59efd-9efd-09d9-e063-6394a90a5e403
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1797059Desitin 40 % Topical PastePSN2c2337cf-4507-7232-e063-6294a90a79c31
1797059Desitin 40 % Topical PastePSN4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1797059Desitin 40 % Topical PastePSN43edc287-57e1-d96e-e063-6294a90ac5a11
1797059Desitin 40 % Topical PastePSN3f838eb7-42a3-c96b-e063-6294a90a74911
828555Tylenol 160 MG in 5 mL Oral SuspensionPSN4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1094560zinc oxide 40 % Topical PastePSN2c2337cf-4507-7232-e063-6294a90a79c31
1094560zinc oxide 40 % Topical PastePSN4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1094560zinc oxide 40 % Topical PastePSN43edc287-57e1-d96e-e063-6294a90ac5a11
1094560zinc oxide 40 % Topical PastePSN3f838eb7-42a3-c96b-e063-6294a90a74911
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBD4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD43edc287-57e1-d96e-e063-6294a90ac5a11
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD3f838eb7-42a3-c96b-e063-6294a90a74911
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD2c2337cf-4507-7232-e063-6294a90a79c31
307668acetaminophen 32 MG/ML Oral SuspensionSCD4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1094560zinc oxide 0.4 MG/MG PasteSCD3f838eb7-42a3-c96b-e063-6294a90a74911
1094560zinc oxide 0.4 MG/MG PasteSCD4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1094560zinc oxide 0.4 MG/MG PasteSCD43edc287-57e1-d96e-e063-6294a90ac5a11
1094560zinc oxide 0.4 MG/MG PasteSCD2c2337cf-4507-7232-e063-6294a90a79c31
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
307668APAP 32 MG/ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
828555APAP 32 MG/ML Oral Suspension [Tylenol]SY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1797059Desitin 40 % Topical PasteSY2c2337cf-4507-7232-e063-6294a90a79c31
1797059Desitin 40 % Topical PasteSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1797059Desitin 40 % Topical PasteSY43edc287-57e1-d96e-e063-6294a90ac5a11
1797059Desitin 40 % Topical PasteSY3f838eb7-42a3-c96b-e063-6294a90a74911
828555Tylenol 160 MG per 5 ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
828555Tylenol 32 MG/ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1094560zinc oxide 40 % PasteSY43edc287-57e1-d96e-e063-6294a90ac5a11
1094560zinc oxide 40 % PasteSY3f838eb7-42a3-c96b-e063-6294a90a74911
1094560zinc oxide 40 % PasteSY2c2337cf-4507-7232-e063-6294a90a79c31
1094560zinc oxide 40 % PasteSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1094560ZNO 0.4 MG/MG PasteSY43edc287-57e1-d96e-e063-6294a90ac5a11
1094560ZNO 0.4 MG/MG PasteSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1094560ZNO 0.4 MG/MG PasteSY3f838eb7-42a3-c96b-e063-6294a90a74911
1094560ZNO 0.4 MG/MG PasteSY2c2337cf-4507-7232-e063-6294a90a79c31
1797059ZNO 0.4 MG/MG Paste [Desitin]SY2c2337cf-4507-7232-e063-6294a90a79c31
1797059ZNO 0.4 MG/MG Paste [Desitin]SY3f838eb7-42a3-c96b-e063-6294a90a74911
1797059ZNO 0.4 MG/MG Paste [Desitin]SY43edc287-57e1-d96e-e063-6294a90ac5a11
1797059ZNO 0.4 MG/MG Paste [Desitin]SY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0848-2699680848021 TUBE in 1 CARTON (69968-0848-2) / 57 g in 1 TUBE1 tube2024-05-14NoNoCurrent