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 22 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petroleum	WHITE PETROLATUM	Harris Teeter	de380df6-cc6e-4b2a-98de-fc08eeb6e8ea	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Hy-Vee, Inc.	45867f42-9562-c111-e063-6394a90adb70	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Lidl US, LLC	c82f236d-c27f-458c-bcd8-19877d09e9a3	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Lidl US, LLC	5e83811f-773f-43e7-bab8-f9e558fb0e00	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Major Pharmaceuticals	c25be68d-834a-4959-8d47-01ec789406ba	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Major Pharmaceuticals	0e7e11c5-a1f8-43c4-b8a6-211491052404	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	d76e116f-4b22-4633-8487-17ad3b5778c7	2026-02-04	Warnings	Exact identifier application number: M016
Comforts Petroleum Jelly	WHITE PETROLATUM	KROGER	3feb3638-1cdc-62d4-e063-6294a90a1d89	2026-02-03	Warnings	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	CVS Pharmacy, Inc.	edc20df4-561e-486f-b9f1-900672a0f2a4	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	CVS Pharmacy, Inc.	a153842c-d9ce-4658-912b-362a6f20b0aa	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Demoulas Super Markets, Inc	702215f0-4cfd-4a23-b47a-da691c136634	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M016
Neurexa	COLLOIDAL OATMEAL	METHODIQ INC.	494d7915-acad-260e-e063-6394a90a182c	2026-02-03	Warnings	Exact identifier application number: M016
Thera Plus Vitamin A and D Cream	DIMETHICONE, ZINC OXIDE	FOURSTAR GROUP USA, INC.	36f09fa4-a3b8-4104-9745-ee60aa493b06	2026-02-02	Warnings	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Kroger Co.	b4aa9b58-d95e-4dac-9a34-213482e8ca34	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M016
Nail Nourishing Pen	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	49e45462-a05f-d370-e063-6394a90a1e0f	2026-02-02	Warnings	Exact identifier application number: M016
Barrier Repair Cream	CREAM	Steel City Health Private Limited	4842f653-7137-eca4-e063-6394a90a8c55	2026-01-31	Warnings	Exact identifier application number: M016
Cracked Heel Repair Balm	DIMETHICONE	Delta Brands Inc.	42b7c9f8-0557-8e33-e063-6394a90a5919	2026-01-30	Warnings	Exact identifier application number: M016
Readybath TPC Total Perineal Care	DIMETHICONE	Medline Industries, Inc.	43a3f0f7-f76f-434d-a21f-7eaa3638913d	2026-01-30	Warnings	Exact identifier application number: M016
Lanolin, Petrolatum	LANOLIN, PETROLATUM	Rite Aid Corporation	1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Rite Aid Corporation	3af9f0e5-0d79-4178-b29e-3b60735bf4ce	2026-01-30	Warnings, Adverse reactions	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