FDA.reportPublic FDA data

Desitin Maximum Strength Zinc Oxide Diaper Rash

Product NDC
69968-0848
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

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 Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui1094560, 1797059

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69968-0848-12024-11-25C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-22024-11-25C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-42024-11-25C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-52024-11-25C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-92024-11-25C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-12024-07-30C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-22024-07-30C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-42024-07-30C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-52024-07-30C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-92024-07-30C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin 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

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
69968-0848-169968084801454 g in 1 JAR (69968-0848-1) 454 g2024-05-14NoNoHistorical
69968-0848-2699680848021 TUBE in 1 CARTON (69968-0848-2) / 57 g in 1 TUBE1 tube2024-05-14NoNoHistorical
69968-0848-3699680848033 TUBE in 1 CARTON (69968-0848-3) / 136 g in 1 TUBE3 tube2024-07-01NoNoHistorical
69968-0848-4699680848041 TUBE in 1 CARTON (69968-0848-4) / 113 g in 1 TUBE1 tube2024-05-14NoNoHistorical
69968-0848-5699680848051 TUBE in 1 CARTON (69968-0848-5) / 136 g in 1 TUBE1 tube2024-05-14NoNoHistorical
69968-0848-9699680848091 TUBE in 1 CARTON (69968-0848-9) / 28 g in 1 TUBE1 tube2024-05-14NoNoHistorical