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 48 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TAN	ZINC OXIDE	Bentley Laboratories, LLC	7920708a-6fa7-4bc8-94ba-096e77d9d7e1	2024-12-27	Warnings	Exact identifier application number: M016
AD Medicated Rash	AD MEDICATED RASH	WellSpring Pharmaceutical Corporation	aac345bf-ea66-4f5b-a497-c24ea72f93ea	2024-12-27	Warnings	Exact identifier application number: M016
ZO Skin Health Post Procedure Recovery System	ALUMINUM ACETATE	ZO Skin Health, Inc.	3b977415-2bf4-43a9-bb48-1eb023ca4f53	2024-12-27	Warnings	Exact identifier application number: M016
terrasil Scar Recovery	ALLANTOIN	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	2a2f91ff-a447-9d2a-e063-6394a90a84f8	2024-12-26	Warnings	Exact identifier application number: M016
WITCH HAZEL	WITCH HAZEL	CHAIN DRUG MARKETING ASSOCIATION INC	bdccee3f-0ad8-4264-a65f-ae86aed6bf03	2024-12-26	Warnings	Exact identifier application number: M016
All Over Lavender Rosemary	COLLOIDAL OAT OINTMENT	Tubby Todd	29f46671-7467-95c9-e063-6294a90a1354	2024-12-23	Warnings	Exact identifier application number: M016
Sweet Cheeks Diaper Sprayer	ZINC OXIDE DIAPER PASTE SPRAY	Tubby Todd	29f4aa3c-d10e-52a5-e063-6294a90acc4b	2024-12-23	Warnings	Exact identifier application number: M016
calamine	CALAMINE AND ZINC OXIDE	WALGREEN COMPANY	fed3026b-3473-26fe-e053-6294a90a8aa2	2024-12-23	Warnings	Exact identifier application number: M016
CUREFINI	PETROLATUM, COD LIVER OIL	Miramar Cosmetics, Inc DBA Miramar Lab	fc9211db-71aa-44d8-a00b-65f1482d3981	2024-12-23	Warnings	Exact identifier application number: M016
CUREFINI	PETROLATUM	Miramar Cosmetics, Inc DBA Miramar Lab	6a2610ca-ca80-451f-8fed-b982443a10b9	2024-12-23	Warnings	Exact identifier application number: M016
Vitamin A and D	LANOLIN, PETROLATUM	Trifecta Pharmaceuticals USA LLC	453dffec-de9d-0eac-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
Vitamin A and D	LANOLIN, PETROLATUM	Trifecta Pharmaceuticals USA LLC	455a16fd-9ce5-6bef-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M016
White Petrolatum	PETROLATUM	Trifecta Pharmaceuticals USA LLC	f1eb0ec2-98e7-13a2-e053-2a95a90a2938	2024-12-20	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Pharmacy Value Alliance, LLC	38018e3f-3778-01d1-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
DiaperRashOintment	ZINC OXIDE	Pharmacy Value Alliance, LLC	3aace6d8-d24c-00e1-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
Medicated Body Powder	MENTHOL	New Pride Corp	f0f0e332-cb93-42a7-e053-2995a90ac4ae	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Medicated Body	MENTHOL AND ZINC OXIDE	International Wholesale Inc dba Home Smart Products	044870e2-ebac-a095-e063-6294a90a2751	2024-12-19	Warnings	Exact identifier application number: M016
White Rain Original Petroleum	WHITE PETROLEUM	INTERNATIONAL WHOLESALE INC.	d6ebe00c-b692-5171-e053-2a95a90a976c	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Original Petroleum	WHITE PETROLEUM	Home Smart Products	aedf746f-4c49-421d-a666-1ba02e8fb17d	2024-12-19	Warnings	Exact identifier application number: M016
white rain Cocoa Butter Petroleum Jelly	WHITE PETROLATUM	INTERNATIONAL WHOLESALE INC.	d7068e2b-c3b2-d16d-e053-2a95a90a6dd2	2024-12-19	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