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 67 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EltaMD Laser Balm	PETROLATUM SKIN PROTECTANT	CP Skin Health Group, Inc	1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb	2023-11-09	Warnings	Exact identifier application number: M016
DiaperDerm Diaper Rash	ZINC OXIDE	Diaperderm Inc	4e1fce3e-c2b7-42da-9953-1dbb13e2467c	2023-11-06	Warnings	Exact identifier application number: M016
Doctors Diaper Rash Cream	ZINC OXIDE	DOCTOR'S DIAPER RASH CREAM, INC	0988ccb1-7881-4d97-bcbf-d0cf4316e4be	2023-11-06	Warnings	Exact identifier application number: M016
DERMOIA Manuka Honey Eczema Cream	OATMEAL	TREASUREWISE LLC	a48e52a3-b681-4489-a1fd-6b09d8bc9c55	2023-11-06	Warnings	Exact identifier application number: M016
GL HEALTH Barrier Skin Protectant	ZINC OXIDE	GL HEALTH, INC.	76cfa330-fea9-48d4-b187-469154765d39	2023-11-06	Warnings	Exact identifier application number: M016
Skin-lube	PETROLATUM, DIMETHICONE	The Hygenic Company, LLC.	d1005dec-04f6-3f88-e053-2a95a90ad9cb	2023-11-05	Warnings	Exact identifier application number: M016
Dr. Sheffield Anti Itch Cream	ANTI ITCH CREAM	Sheffield Pharmaceuticals LLC	77f0593e-f694-4c02-9fd9-ad56ff2a920c	2023-10-30	Warnings	Exact identifier application number: M016
calahist	CALAMINE AND PRAMOXINE HYDROCHLORIDE	WALGREEN COMPANY	fed45e06-cc53-fbc5-e053-6294a90a1b19	2023-10-27	Warnings	Exact identifier application number: M016
calahist clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	WALGREEN COMPANY	fed469c2-fe13-6726-e053-6394a90a5f51	2023-10-27	Warnings	Exact identifier application number: M016
Dr. Sayman Salve	SALVE	Sheffield Pharmaceuticals LLC	18bdcd0c-9c81-47e1-ae24-2239ff8fd066	2023-10-24	Warnings	Exact identifier application number: M016
Theriac Advanced Healing	LANOLIN	Sheffield Pharmaceuticals LLC	c780cd27-dc9e-45f3-97f0-e59b1b6b955a	2023-10-24	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	d66e369e-9b19-b084-e053-2995a90aa259	2023-10-23	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Healing	COLLOIDAL OATMEAL	Babo Botanicals, Inc.	08659a5c-2d10-2f98-e063-6394a90a7760	2023-10-23	Warnings	Exact identifier application number: M016
White Rose Petroleum Jelly	PETROLATUM	J. Strickland & Co.	1aeb090d-c103-4c2e-accc-d9d248315db9	2023-10-21	Warnings	Exact identifier application number: M016
Tricalm Hydrogel	ALUMINUM ACETATE	MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES	082c6441-be47-4466-e063-6394a90ad500	2023-10-20	Warnings	Exact identifier application number: M016
Empower	WHITE PETROLATUM, ZINC OXIDE	Bemis Manufacturing Company Inc	08006b60-966b-155b-e063-6294a90a206a	2023-10-18	Warnings	Exact identifier application number: M016
ANUBISMED	HA HYALURONIC	ANUBIS COSMETICS SL	eac771e2-4c1b-3808-e053-2995a90ac5fc	2023-09-05	Warnings	Exact identifier application number: M016
AnubisMed	SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA	ANUBIS COSMETICS SL	ebf4b3ab-34e1-185a-e053-2a95a90ace3a	2023-09-05	Warnings	Exact identifier application number: M016
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE	ANUBIS COSMETICS SL	f22b212d-d21d-5984-e053-2995a90a683e	2023-09-01	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