Calamine

Product NDC: 75981-063
11-digit product format: 759810063
Labeler code: 75981
Product ID: 75981-063_4b30bf8c-4f51-f880-e063-6294a90a8f77
Type: HUMAN OTC DRUG
Nonproprietary name: FERRIC OXIDE RED
Dosage form: LOTION
Route: TOPICAL
Labeler: Perrigo Direct, Inc�
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1992-09-15
Substance: FERRIC OXIDE RED; ZINC OXIDE
Active strength: 8; 8 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	8 mg/mL
ZINC OXIDE	8 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
256bd1d4-fd50-408f-9aee-84f218bb4971	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75981-063-30	Calamine	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75981-063-30	ML - Milliliter	75981-063	1ffc2907-5e98-4cd3-9e5f-e425c5335bed	1	2016-12-07

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 [GEISS, DESTIN AND DUNN, INC]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC]	1
FERRIC OXIDE RED	ACTIVE MOIETY	1K09F3G675	CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC]	1
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC]	1
CALCIUM HYDROXIDE	INACTIVE INGREDIENT	PF5DZW74VN	CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75981-063	CALAMINE (FERRIC OXIDE RED) LOTION [PERRIGO DIRECT, INC.]	8	Current NDC, Legacy NDC, 1 package rows	20250410_256bd1d4-fd50-408f-9aee-84f218bb4971.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 17 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Old East Main Co.	91df1434-bce6-4c6e-beee-cb5ec1cc8fff	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Old East Main Co.	cf916191-1de2-4305-b783-9e074c1ad94b	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Eczema Relief	COLLOIDAL OATMEAL	Old East Main Co.	b2dba027-c295-4a41-8d30-144904e1aa34	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Old East Main Co.	9720e2ad-1bcf-4023-8e92-22a962df3aad	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Chain Drug Marketing Association	86ff4875-9007-4b7b-8f46-16cbd475d4bb	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Chain Drug Marketing Association	1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Chain Drug Marketing Association	6c848b98-f01c-40f2-a9aa-2af76cb370c8	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	The Kroger Co.	fcffbe1f-79b8-451a-9384-19533b81d8c8	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	The Kroger Co.	d2095c7b-61ca-40d3-bbf1-04bed4dd789c	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	The Kroger Co.	ea8b186c-82d5-4552-bcce-03e56023ea99	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash Cream	ZINC OXIDE	Smalls Brand LLC DBA Roe Wellness	4bd29285-29b4-5d57-e063-6294a90af481	2026-02-27	Warnings	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Walmart Inc.	5893801a-25e1-4750-a55b-d9cddd3f1284	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Walmart Inc.	320bcbd3-9e91-437f-99c5-066f880a4b32	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Skin Protectant	PETROLATUM	Walmart Inc.	eb836922-f467-42ab-a6e7-b787d97e6c17	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Walmart Inc.	aa7dbf7f-50be-475b-8140-68be3fa93507	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
White Petrolatum	WHITE PETROLATUM	Walmart Inc.	176d7711-7c4f-4319-91af-0aba1260c412	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Soothing Moisturizing	COLLOIDAL OATMEAL	Walmart Inc.	2d813455-c268-4c6d-9952-eaf0e0007d90	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Rapid Repair Healing Cream	ALLANTOIN, DIMETHICONE	June Jacobs Labs LLC	186c13be-5e41-b9c9-e063-6294a90ad574	2026-02-26	Warnings	Exact identifier application number: M016
Lanashield	LANOLIN	Dynarex Corporation	94b277dc-6512-4d36-8485-8ea510097428	2026-02-26	Warnings	Exact identifier application number: M016
GLADSKIN ECZEMACT ECZEMA	COLLOIDAL OATMEAL	Micreos North America, Inc.	06f9af75-c5ff-d37b-e063-6394a90a4f6c	2026-02-25	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	256bd1d4-fd50-408f-9aee-84f218bb4971	9
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	256bd1d4-fd50-408f-9aee-84f218bb4971	9
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	256bd1d4-fd50-408f-9aee-84f218bb4971	9
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	256bd1d4-fd50-408f-9aee-84f218bb4971	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75981-063-30	75981006330	177 mL in 1 BOTTLE, PLASTIC (75981-063-30)	177 ml	1992-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Good Sense 063.001/063AA Calamine Lotion	Perrigo Direct, Inc \| Nice-Pak Products, LLC	2026-02-19	HUMAN OTC DRUG LABEL	9