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 35 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Witch Hazel	WITCH HAZEL	Meijer Distribution Inc	03f23b04-e7f7-49b7-e063-6294a90ad58a	2025-10-31	Warnings	Exact identifier application number: M016
Diaper Rash skin protectant	LANOLIN AND PETROLATUM	Universal Distribution Centre LLC	1852246a-6a1c-49ab-e063-6294a90a9048	2025-10-30	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	20b531c1-9ab0-5ff1-e063-6394a90a2975	2025-10-30	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	20b650bd-18fe-8696-e063-6394a90aa9a2	2025-10-30	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	20b5f354-3379-3d9f-e063-6294a90ae817	2025-10-30	Warnings	Exact identifier application number: M016
Boudreauxs	ZINC OXIDE	C.B. Fleet Company, Inc.	59d90652-a471-4f77-a3d5-88aad9dc9e13	2025-10-30	Warnings	Exact identifier application number: M016
CVS Cools Itch Fast	HYDROCORTISONE	CVS Pharmacy, Inc.	8a4544df-bbba-47d2-ada0-352757abc91f	2025-10-29	Warnings	Exact identifier application number: M016
Winco Maximum Strength Hydrocortisone	HYDROCORTISONE	WINCO FOODS, LLC	b1812ea3-78cc-607a-e053-2a95a90a0a10	2025-10-29	Warnings	Exact identifier application number: M016
Good Neighbor Pharmacy Skin Protectant	ZINC OXIDE	AMERISOURCE BERGEN	c28e63f1-34be-9206-e053-2995a90accf6	2025-10-29	Warnings	Exact identifier application number: M016
Remedy Nutrashield	DIMETHICONE	Medline Industries, LP	ed8a08a7-594c-46e2-b70f-b75b2960141f	2025-10-28	Warnings	Exact identifier application number: M016
American Red Cross Anti-Itch	HYDROCORTISONE 1.0%(W/W)	MY IMPORTS USA LLC	421da126-a1c4-54d7-e063-6394a90ac401	2025-10-27	Warnings	Exact identifier application number: M016
GeriGard	ZINC OXIDE	Geri-Gentle Corporation	05b67830-adc8-46b1-b0a0-a6cd2875e80c	2025-10-27	Warnings	Exact identifier application number: M016
Boudreauxs Butt Barrier	DIMETHICONE	C.B. Fleet Company, Inc.	06a5af4d-40dd-42a4-8368-4d6a772d1b3a	2025-10-27	Warnings	Exact identifier application number: M016
Boudreauxs Baby Shower Bundle	ZINC OXIDE	C.B. Fleet Company, Inc.	a289ed3c-3c7a-4eda-bf5e-139203d2e17e	2025-10-27	Warnings	Exact identifier application number: M016
WinCo Original Strength Anti-Itch	DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE	WinCo Foods, LLC	ae74e163-ba1a-4d1e-aaeb-9976bd202674	2025-10-24	Warnings	Exact identifier application number: M016
Maximum Strength Moisture Barrier	PETROLATUM AND ZINC OXIDE	Derma Sciences Canada Inc.	41ee91c0-d196-cc0f-e063-6394a90a7b97	2025-10-24	Warnings	Exact identifier application number: M016
Tenderphor	SKIN PROTECTANT	GERI-GENTLE CORPORATION	e6763da3-cbd1-7a86-e053-2995a90a26c1	2025-10-23	Warnings	Exact identifier application number: M016
Boudreauxs	ZINC OXIDE	C.B. Fleet Company, Inc.	262278f6-7e4c-44ee-b40d-39662a239d73	2025-10-23	Warnings	Exact identifier application number: M016
American Red Cross Anti-Itch	HYDROCORTISONE 1.0%(W/W)	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41b8cb00-a04e-52f0-e063-6294a90aabf7	2025-10-22	Warnings	Exact identifier application number: M016
WinCo Foods Hydrocortisone Cream Intensive Healing	HYDROCORTISONE	WINCO FOODS, LLC	ac4e0e24-9295-b83b-e053-2995a90a996f	2025-10-22	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