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 17 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Old East Main Co.	91df1434-bce6-4c6e-beee-cb5ec1cc8fff	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Old East Main Co.	cf916191-1de2-4305-b783-9e074c1ad94b	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Eczema Relief	COLLOIDAL OATMEAL	Old East Main Co.	b2dba027-c295-4a41-8d30-144904e1aa34	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Old East Main Co.	9720e2ad-1bcf-4023-8e92-22a962df3aad	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Chain Drug Marketing Association	86ff4875-9007-4b7b-8f46-16cbd475d4bb	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Chain Drug Marketing Association	1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Chain Drug Marketing Association	6c848b98-f01c-40f2-a9aa-2af76cb370c8	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	The Kroger Co.	fcffbe1f-79b8-451a-9384-19533b81d8c8	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	The Kroger Co.	d2095c7b-61ca-40d3-bbf1-04bed4dd789c	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	The Kroger Co.	ea8b186c-82d5-4552-bcce-03e56023ea99	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash Cream	ZINC OXIDE	Smalls Brand LLC DBA Roe Wellness	4bd29285-29b4-5d57-e063-6294a90af481	2026-02-27	Warnings	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Walmart Inc.	5893801a-25e1-4750-a55b-d9cddd3f1284	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Walmart Inc.	320bcbd3-9e91-437f-99c5-066f880a4b32	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Skin Protectant	PETROLATUM	Walmart Inc.	eb836922-f467-42ab-a6e7-b787d97e6c17	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Walmart Inc.	aa7dbf7f-50be-475b-8140-68be3fa93507	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
White Petrolatum	WHITE PETROLATUM	Walmart Inc.	176d7711-7c4f-4319-91af-0aba1260c412	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Soothing Moisturizing	COLLOIDAL OATMEAL	Walmart Inc.	2d813455-c268-4c6d-9952-eaf0e0007d90	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Rapid Repair Healing Cream	ALLANTOIN, DIMETHICONE	June Jacobs Labs LLC	186c13be-5e41-b9c9-e063-6294a90ad574	2026-02-26	Warnings	Exact identifier application number: M016
Lanashield	LANOLIN	Dynarex Corporation	94b277dc-6512-4d36-8485-8ea510097428	2026-02-26	Warnings	Exact identifier application number: M016
GLADSKIN ECZEMACT ECZEMA	COLLOIDAL OATMEAL	Micreos North America, Inc.	06f9af75-c5ff-d37b-e063-6394a90a4f6c	2026-02-25	Warnings	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