DERMOGEN

Product NDC: 52083-680
11-digit product format: 520830680
Labeler code: 52083
Product ID: 52083-680_2a461bfd-7006-4b64-addf-474ee1fbd48f
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: KRAMER NOVIS
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-04-04
Substance: ZINC OXIDE
Active strength: 15.25 g/100g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52083-680-04	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52083-680-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52083-680-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52083-680-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52083-680-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52083-680-04	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52083-680-04	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52083-680-04	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: DERMOGEN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	15.25 g/100g

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1793915	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
38e02d1c-c143-4da6-ad32-a3ce2861aac5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52083-680-04	2025-11-18	C162847	48780-1	2cef2736-6d14-d83d-e063-dadaa90ab31f	DERMOGEN (Zinc Oxide Cream)
52083-680-04	2025-01-30	C162847	48780-1	2cef2736-6d14-d83d-e063-dadaa90ab31f	DERMOGEN (Zinc Oxide Cream)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-680-04	DERMOGEN	113.4 g in 1 JAR	CREAM	113.4		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-680	DERMOGEN (ZINC OXIDE) CREAM [KRAMER NOVIS]	2	Current NDC, Legacy NDC, 1 package rows	20181207_38e02d1c-c143-4da6-ad32-a3ce2861aac5.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 20 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diaper Rash	ZINC OXIDE	Target Corporation	8059f489-f144-4de5-9454-ac6c1af35dd2	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Coconut Milk and Shea Petroleum Jelly	WHITE PETROLATUM	Target Corporation	c78d9864-92e0-4ad8-8a9b-9752ac6784e8	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Strategic Sourcing Services LLC	043375b2-e636-4822-9e05-df2327d29986	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Strategic Sourcing Services LLC	3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Valu Merchandisers Company	4113bb6e-070a-4116-a8d6-12c6b4475beb	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Valu Merchandisers Company	e5465ddd-e38c-44a4-bb9b-3edbc636576d	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Valu Merchandisers Company	8b8decec-e921-4ff9-bb49-7e38e34724f6	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Valu Merchandisers Company	0cccadd7-11f3-5d1f-e063-6294a90a55c4	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Valu Merchandisers Company	7c6fa37f-79b8-4409-b7a9-3f02332f887a	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	United Natural Foods, Inc. dba UNFI	014d0028-486e-4f1c-a14f-8162e393ebca	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	United Natural Foods, Inc. dba UNFI	29a3a719-5e8b-407d-b9d9-bdba26758292	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Topco Associates LLC	8acb1b47-70ed-4aa2-a7c0-e807042affc7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Topco Associates LLC	2b32e720-ac71-4d60-bc06-e28a00f8a450	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Topco Associates LLC	3babe2cf-9e6c-4f22-940f-c1fdf489f1c7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti Itch	PRAMOXINE HCL, ZINC ACETATE	Topco Associates LLC	8d3d1ff5-4868-495d-807c-e45aa2176f63	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Healing	PETROLATUM	Topco Associates LLC	b929b159-4af5-4a03-8e7c-676a6ba2bf55	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Topco Associates LLC	15d1ae3f-509c-4e6b-8f0c-cf9265680358	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Topco Associates LLC	cd7f1727-0b6e-4993-9820-43783994efa1	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	Topco Associates LLC	f37f17f7-f084-4b74-8361-178d2315a476	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Topco Associates LLC	4f6af42c-f41e-455f-b94b-3793bf0b9a3f	2026-02-13	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
1793915	zinc oxide 15.25 % Topical Cream	PSN	38e02d1c-c143-4da6-ad32-a3ce2861aac5	3
1793915	zinc oxide 153 MG/ML Topical Cream	SCD	38e02d1c-c143-4da6-ad32-a3ce2861aac5	3
1793915	zinc oxide 15.25 % Topical Cream	SY	38e02d1c-c143-4da6-ad32-a3ce2861aac5	3
1793915	ZNO 153 MG/ML Topical Cream	SY	38e02d1c-c143-4da6-ad32-a3ce2861aac5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-680-04	52083068004	113.4 g in 1 JAR (52083-680-04)	113.4 g	2016-04-04	0000-00-00	No	No	Current