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 15 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	36f3b300-f32f-8881-e063-6394a90a1a2a	2026-03-26	Warnings	Exact identifier application number: M016
White Petrolatum	PETROLATUM	Dynarex Corporation	81f5092d-0632-bf47-e053-2991aa0ac563	2026-03-25	Warnings	Exact identifier application number: M016
MYEVER	ESTRIOL CREAM	Hubei Redrui Building Materials Co., Ltd.	3ed85485-a441-4c05-e063-6394a90afef5	2026-03-25	Warnings	Exact identifier application number: M016
Softlips Peppermint Swirl	DIMETHICONE	The Mentholatum Company	4dbea50e-d82d-c702-e063-6394a90ac6e4	2026-03-24	Warnings	Exact identifier application number: M016
Softlips Vanilla	DIMETHICONE	The Mentholatum Company	56551008-a4e0-406f-8403-980d2e6b75a0	2026-03-24	Warnings	Exact identifier application number: M016
Selan Plus Zinc Oxide	SELAN PLUS ZINC OXIDE	Trividia Manufacturing Solutions, Inc	07396c61-1dfd-4be7-bddf-0eb570a18463	2026-03-24	Warnings	Exact identifier application number: M016
D-Cerin	MOISTURIZER	Dynarex Corporation	7ea47a7e-12af-9290-e053-2a91aa0a065f	2026-03-24	Warnings	Exact identifier application number: M016
MG217 Eczema Body	COLLOIDAL OATMEAL	Wisconsin Pharmacal Company	5f0cfd0c-ae87-f411-e053-2a91aa0ac251	2026-03-20	Warnings	Exact identifier application number: M016
Advanced Formula Scar Defense Cream	ALLANTOIN	Yantai Aien Biotechnology Co., Ltd.	4d5c70f9-da41-b535-e063-6294a90a73f2	2026-03-19	Warnings	Exact identifier application number: M016
TriplePaste Adult Care Rash Treatment	ZINC OXIDE	Advantice Health, LLC	2cf0575c-8d3d-1f16-e063-6294a90a629d	2026-03-19	Warnings	Exact identifier application number: M016
multipurpose	ZINC OXIDE SKIN PROTECTANT	Advantice Health, LLC	291563cc-7491-ce41-e063-6394a90ac6c1	2026-03-19	Warnings	Exact identifier application number: M016
Triple Diaper Rash	ZINC OXIDE	Advantice Health, LLC	d457c58d-8239-41c4-999e-d0ba237e3945	2026-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	f4464fb2-ba25-16f2-e053-2a95a90a0406	2026-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Cookie	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	fea4e5c7-780c-c7f4-e053-6294a90abb39	2026-03-19	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	4d46110b-5aa7-5261-e063-6394a90a423a	2026-03-18	Warnings	Exact identifier application number: M016
Advanced Bed Sore Wound Healing	ALLANTOIN	Yantai Aien Biotechnology Co., Ltd.	4d589c18-e597-355a-e063-6394a90a4243	2026-03-18	Warnings	Exact identifier application number: M016
MediChoice Barrier	DIMETHICONE	O&M HALYARD, INC.	115c2a2f-d68a-316a-e063-6394a90a2716	2026-03-17	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	4d4427b0-25c3-ddf6-e063-6394a90a6153	2026-03-17	Warnings	Exact identifier application number: M016
Colloidal Oatmeal	COLLOIDAL OATMEAL	Walmart Inc.	4a93f77d-41dc-3bab-e063-6394a90a804b	2026-03-16	Warnings, Adverse reactions	Exact identifier application number: M016
Vaseline	HEALING JELLY	Conopco Inc. d/b/a Unilever	bd4418b7-c6aa-5e71-e053-2995a90a4cc4	2026-03-16	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