Calamine

Product NDC: 0904-2533
11-digit product format: 009042533
Labeler code: 0904
Product ID: 0904-2533_4a057dbb-483c-a4b4-e063-6394a90aa36a
Type: HUMAN OTC DRUG
Nonproprietary name: FERRIC OXIDE RED
Dosage form: LOTION
Route: TOPICAL
Labeler: Major Pharmaceuticals
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-01-07
Substance: FERRIC OXIDE RED; ZINC OXIDE
Active strength: 80; 80 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Calamine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERRIC OXIDE RED	80 mg/mL
ZINC OXIDE	80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1K09F3G675	Internal UNII lookup
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
617954	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
c25be68d-834a-4959-8d47-01ec789406ba	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-2533-21	Calamine	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-2533-21	ML - Milliliter	0904-2533	918d193f-eb73-474a-b375-ecfe47fd756e	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FERRIC OXIDE RED	ACTIVE INGREDIENT	1K09F3G675	CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]	1
FERRIC OXIDE RED	ACTIVE MOIETY	1K09F3G675	CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]	1
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]	1
CALCIUM HYDROXIDE	INACTIVE INGREDIENT	PF5DZW74VN	CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-2533	CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]	13	Current NDC, Legacy NDC, 1 package rows	20250412_c25be68d-834a-4959-8d47-01ec789406ba.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 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Vaseline Intensive Care Deep Moisture	PETROLEUM	Conopco Inc. d/b/a Unilever	65cec560-25c7-4076-a33d-a3dd534ff85b	2026-03-16	Warnings	Exact identifier application number: M016
Daily Moisturizing	DAILY MOISTRUIZING	Walgreen Co.	27452cc7-1ec6-4571-bcd0-0a7103735ee5	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M016
Tender Moments Delicate Baby Diaper Rash Balm	DIMETHICONE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	f09ba452-e1a6-4f45-901f-bb63d4f8e884	2026-03-13	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K09F3G675	FERRIC OXIDE RED	1309-37-1	FERRIC OXIDE RED
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	PSN	c25be68d-834a-4959-8d47-01ec789406ba	15
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	c25be68d-834a-4959-8d47-01ec789406ba	15
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	c25be68d-834a-4959-8d47-01ec789406ba	15
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	c25be68d-834a-4959-8d47-01ec789406ba	15
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	PSN	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	6
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	6
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	6
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	6
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	PSN	66e98554-e158-a519-e053-2a91aa0a6783	5
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	66e98554-e158-a519-e053-2a91aa0a6783	5
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	66e98554-e158-a519-e053-2a91aa0a6783	5
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	66e98554-e158-a519-e053-2a91aa0a6783	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-2533-21	00904253321	177 mL in 1 BOTTLE, PLASTIC (0904-2533-21)	177 ml	2013-01-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major 063.001/063AA Calamine Lotion	Major Pharmaceuticals \| Nice-Pak Products, LLC	2026-02-04	HUMAN OTC DRUG LABEL	15
Major 063.001 063AA	Preferred Pharmaceuticals Inc.	2025-02-12	HUMAN OTC DRUG LABEL	6
Drug Facts	NuCare Pharmaceuticals,Inc.	2024-06-06	HUMAN OTC DRUG LABEL	5