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 12 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doue Pure petroleum Original	PETROLATUM	ONEST LIMITED	57188500-fccf-4348-af4f-cf22324cf29e	2026-05-01	Warnings	Exact identifier application number: M016
Herpecin L	DIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONE	Focus Consumer Healthcare, LLC	5b6ed4e9-3e69-c773-e053-2991aa0a7dfe	2026-05-01	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Retail Business Services, LLC	7291e175-a9b6-4c47-93ce-227ce11e4599	2026-04-30	Warnings, Adverse reactions	Exact identifier application number: M016
Herpecin Pain Relief	ALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCL	Focus Consumer Healthcare, LLC	beeb6043-6547-4fe9-e053-2995a90a5d74	2026-04-30	Warnings	Exact identifier application number: M016
CVS	PETROLATUM	Apollo Health and Beauty Care	47d2b9be-91ad-e9e2-e063-6294a90ac29f	2026-04-30	Warnings	Exact identifier application number: M016
Dr. Numb	LIDOCAINE	Shinpharma Inc	0578fbcb-875a-4606-acde-dcecb29756e6	2026-04-30	Warnings	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	Amazon.com Services LLC	423c821d-92af-47f0-b9ee-8b68ecbcc44e	2026-04-29	Warnings, Adverse reactions	Exact identifier application number: M016
MICRO INFUSIONSYSTEM	SEEK GLO	Ningbo Kenwei International Trade Co., Ltd.	50746cab-bfcc-fe0b-e063-6394a90adc01	2026-04-27	Warnings	Exact identifier application number: M016
Pharmacy Choice	MENTHOL, ZINC OXIDE	PHARMACY CHOICE INC	5031fc05-e1c7-40b1-e063-6394a90aa12c	2026-04-24	Warnings	Exact identifier application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTION	SEL PH BABY PH-BALANCED ECZEMA DRYNESS BABY	Guangzhou Ariel Biotech Co., Ltd.	5040b707-87af-3859-e063-6294a90afb3d	2026-04-24	Warnings	Exact identifier application number: M016
Caldesene Baby	STARCH, CORN AND ZINC OXIDE	Insight Pharmaceuticals LLC	9f12dee2-7afa-45e9-a729-0fd42bb77715	2026-04-22	Warnings	Exact identifier application number: M016
Caldesene Medicated Protecting	CORNSTARCH AND ZINC OXIDE	Insight Pharmaceuticals LLC	ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b	2026-04-22	Warnings	Exact identifier application number: M016
Arm and Hammer Baking Soda	SODIUM BICARBONATE	Church & Dwight Co., Inc.	643fe204-4a7b-00e4-e053-2a91aa0aef06	2026-04-21	Warnings	Exact identifier application number: M016
PURE PETROLATUM	PETROLATUM	MY IMPORTS USA LLC	4fba8bc7-590d-f621-e063-6294a90ad8c9	2026-04-18	Warnings	Exact identifier application number: M016
Anti-Itch Regular Strength	HYDROCORTISONE	CVS Pharmacy	9fe7768b-9023-c9ee-e053-2a95a90a55b3	2026-04-17	Warnings	Exact identifier application number: M016
Calamine Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Pharma Nobis, LLC	4f853183-5925-2c73-e063-6394a90adf6c	2026-04-15	Warnings	Exact identifier application number: M016
Freskaro Calamine Plus	ZINC OXIDE LOTION	Pharma Nobis, LLC	4f85bdc7-8fed-f1f5-e063-6394a90a6358	2026-04-15	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE OINTMENT	Dynarex Corporation	11d79dd6-35f7-4399-e063-6294a90ac7dd	2026-04-13	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	4f261746-37e9-7b30-e063-6294a90a9224	2026-04-10	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	4f268501-6cd7-7edd-e063-6294a90ac649	2026-04-10	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