Desitin Maximum Strength Diaper Rash

Product NDC: 69968-0061
11-digit product format: 699680061
Labeler code: 69968
Product ID: 69968-0061_26dd439f-d784-6c9b-e063-6394a90a3eff
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: 2015-11-16
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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69968-0061-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69968-0061-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69968-0061-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69968-0061-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69968-0061-7	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69968-0061-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69968-0061-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69968-0061-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69968-0061-9	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69968-0061-5	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69968-0061-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69968-0061-7	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69968-0061-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69968-0061-1	`367a005e9d99…`	`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 Diaper Rash
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	400 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
af64fc2f-c027-4a68-b368-ee06744a2452	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69968-0061-1	2024-11-25	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-2	2024-11-25	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-3	2024-11-25	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-4	2024-11-25	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-5	2024-11-25	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-7	2024-11-25	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-9	2024-11-25	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-1	2024-07-30	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-2	2024-07-30	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-3	2024-07-30	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-4	2024-07-30	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-5	2024-07-30	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-7	2024-07-30	Desitin ® Maximum Strength Diaper Rash Paste
69968-0061-9	2024-07-30	Desitin ® Maximum Strength Diaper Rash Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69968-0061-1	Desitin Maximum Strength Diaper Rash	1 in 1 CARTON	PASTE	1		8
69968-0061-1	Desitin Maximum Strength Diaper Rash	28 g in 1 TUBE	PASTE	28		8
69968-0061-2	Desitin Maximum Strength Diaper Rash	57 g in 1 TUBE	PASTE	57		8
69968-0061-2	Desitin Maximum Strength Diaper Rash	1 in 1 CARTON	PASTE	1		8
69968-0061-3	Desitin Maximum Strength Diaper Rash	136 g in 1 TUBE	PASTE	136		8
69968-0061-3	Desitin Maximum Strength Diaper Rash	3 in 1 CARTON	PASTE	3		8
69968-0061-4	Desitin Maximum Strength Diaper Rash	113 g in 1 TUBE	PASTE	113		8
69968-0061-4	Desitin Maximum Strength Diaper Rash	1 in 1 CARTON	PASTE	1		8
69968-0061-5	Desitin Maximum Strength Diaper Rash	1 in 1 CARTON	PASTE	1		8
69968-0061-5	Desitin Maximum Strength Diaper Rash	136 g in 1 TUBE	PASTE	136		8
69968-0061-7	Desitin Maximum Strength Diaper Rash	3.5 g in 1 POUCH	PASTE	3.5		8
69968-0061-9	Desitin Maximum Strength Diaper Rash	454 g in 1 JAR	PASTE	454		8
69968-0061-1	Johnsons Baby Care Essentials Gift Set	1 in 1 CARTON	PASTE		400 mg in 1g	4
69968-0061-1	Johnsons Baby Care Essentials Gift Set	28 g in 1 TUBE	PASTE	28 g	400 mg in 1g	4
69968-0061-1	Johnsons Baby Care Essentials Gift Set	1 in 1 CARTON	PASTE		400 mg in 1g	3
69968-0061-1	Johnsons Baby Care Essentials Gift Set	28 g in 1 TUBE	PASTE	28 g	400 mg in 1g	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69968-0061-1	GM - Gram	69968-0061	f10dbdb2-0d9b-41ce-b70a-58f111649b9f	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69968-0061	DESITIN MAXIMUM STRENGTH DIAPER RASH (ZINC OXIDE) PASTE [KENVUE BRANDS LLC]	8	Current NDC, Legacy NDC, 12 package rows	20241127_af64fc2f-c027-4a68-b368-ee06744a2452.zip
69968-0061	JOHNSONS BABY CARE ESSENTIALS GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]	4	Current NDC, Legacy NDC	20241115_afa1ba48-b504-4af0-a9c7-cd2c9a2e6e59.zip
69968-0061	JOHNSONS BABY CARE ESSENTIALS GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]	3	Current NDC, Legacy NDC	20241127_ed08b690-f907-6d2f-e053-2a95a90af51c.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 19 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine	FERRIC OXIDE RED	Perrigo Direct, Inc	256bd1d4-fd50-408f-9aee-84f218bb4971	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Perrigo Direct, Inc	e11470b2-80d6-4008-b87e-eb6aeadfce74	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Perrigo Direct, Inc	cc0378f2-6d5f-47ec-b16a-64668b4c29cc	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXIND HCL	Perrigo Direct, Inc	54a20ec9-ab86-4410-af94-e04393e9d4b3	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Meijer, Inc.	adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Meijer, Inc.	1b72f927-c2ae-4190-a035-5d7bb9f53c15	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Meijer, Inc.	af293cc0-ccd5-42a6-861b-c19fa6ffd06a	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Healing for Babies	PETROLATUM	Meijer, Inc.	09878fe0-0890-4af3-a3f6-d2890041e9f8	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Meijer, Inc.	fa8ae34c-7b68-454f-8a3b-0eaa93a34092	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Diaper Rash	ZINC OXIDE	Meijer, Inc.	04bec667-a11e-42d2-a4b3-1416eebf1e8d	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Healing	PETROLATUM	Meijer, Inc.	8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c1	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Meijer, Inc.	6b369ef2-fd54-4931-a9eb-0fb42834c2ef	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	Meijer, Inc.	75b91b97-ea84-4c4d-9e58-5a9ff27a778c	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	Meijer, Inc.	d36a7479-7b3b-49fe-8144-b5cce0e173fb	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DAILY MOISTURIZING	Meijer, Inc.	44949b46-70f2-4e52-adba-a8455da614eb	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Meijer, Inc.	13e4aece-5b91-4f89-a912-540bf170a8d1	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Target Corporation	7fb5f9ca-cd90-4933-9fe8-907ece00458b	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Target Corporation	d4ee05c8-ae62-45df-8783-1ed57fa030ec	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Target Corporation	5237c7f2-7135-4558-a758-4fc2a232172f	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Target Corporation	3e620e4f-9e29-9e39-e063-6394a90adeda	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1797059	Desitin 40 % Topical Paste	PSN	af64fc2f-c027-4a68-b368-ee06744a2452	8
1094560	zinc oxide 40 % Topical Paste	PSN	af64fc2f-c027-4a68-b368-ee06744a2452	8
1797059	zinc oxide 0.4 MG/MG Paste [Desitin]	SBD	af64fc2f-c027-4a68-b368-ee06744a2452	8
1094560	zinc oxide 0.4 MG/MG Paste	SCD	af64fc2f-c027-4a68-b368-ee06744a2452	8
1797059	Desitin 40 % Topical Paste	SY	af64fc2f-c027-4a68-b368-ee06744a2452	8
1094560	zinc oxide 40 % Paste	SY	af64fc2f-c027-4a68-b368-ee06744a2452	8
1094560	ZNO 0.4 MG/MG Paste	SY	af64fc2f-c027-4a68-b368-ee06744a2452	8
1797059	ZNO 0.4 MG/MG Paste [Desitin]	SY	af64fc2f-c027-4a68-b368-ee06744a2452	8
1797059	Desitin 40 % Topical Paste	PSN	ed08b690-f907-6d2f-e053-2a95a90af51c	3
1094560	zinc oxide 40 % Topical Paste	PSN	ed08b690-f907-6d2f-e053-2a95a90af51c	3
1797059	zinc oxide 0.4 MG/MG Paste [Desitin]	SBD	ed08b690-f907-6d2f-e053-2a95a90af51c	3
1094560	zinc oxide 0.4 MG/MG Paste	SCD	ed08b690-f907-6d2f-e053-2a95a90af51c	3
1797059	Desitin 40 % Topical Paste	SY	ed08b690-f907-6d2f-e053-2a95a90af51c	3
1094560	zinc oxide 40 % Paste	SY	ed08b690-f907-6d2f-e053-2a95a90af51c	3
1094560	ZNO 0.4 MG/MG Paste	SY	ed08b690-f907-6d2f-e053-2a95a90af51c	3
1797059	ZNO 0.4 MG/MG Paste [Desitin]	SY	ed08b690-f907-6d2f-e053-2a95a90af51c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69968-0061-1	69968006101	1 TUBE in 1 CARTON (69968-0061-1) / 28 g in 1 TUBE	1 tube	2015-11-16	0000-00-00	No	No	Current
69968-0061-2	69968006102	1 TUBE in 1 CARTON (69968-0061-2) / 57 g in 1 TUBE	1 tube	2015-11-16	0000-00-00	No	No	Current
69968-0061-3	69968006103	3 TUBE in 1 CARTON (69968-0061-3) / 136 g in 1 TUBE	3 tube	2015-11-16	0000-00-00	No	No	Current
69968-0061-4	69968006104	1 TUBE in 1 CARTON (69968-0061-4) / 113 g in 1 TUBE	1 tube	2015-11-16	0000-00-00	No	No	Current
69968-0061-5	69968006105	1 TUBE in 1 CARTON (69968-0061-5) / 136 g in 1 TUBE	1 tube	2015-11-16	0000-00-00	No	No	Current
69968-0061-7	69968006107	3.5 g in 1 POUCH (69968-0061-7)	3.5 g	2015-11-16	0000-00-00	No	No	Current
69968-0061-9	69968006109	454 g in 1 JAR (69968-0061-9)	454 g	2015-11-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Johnson's ® Baby Care Essentials Gift Set	Kenvue Brands LLC	2024-11-25	HUMAN OTC DRUG LABEL	3
Desitin ® Maximum Strength Diaper Rash Paste	Kenvue Brands LLC	2024-11-15	HUMAN OTC DRUG LABEL	8
Desitin ® Maximum Strength Zinc Oxide Diaper Rash Paste	Johnson & Johnson Consumer Inc.	2023-05-02	HUMAN OTC DRUG LABEL	4
Johnsons ® tiny traveler Gift Set Desitin ® Maximum Strength Diaper Rash	Johnson & Johnson Consumer Inc.	2022-02-25	HUMAN OTC DRUG LABEL	2