Humco Calamine

Product NDC: 0395-0413
11-digit product format: 003950413
Labeler code: 0395
Product ID: 0395-0413_52b9f60d-7ae7-26c8-e063-6294a90acc20
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine 8% and Zinc Oxide 8%
Dosage form: LOTION
Route: TOPICAL
Labeler: Humco holding Group, Inc.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1998-03-25
Substance: ZINC OXIDE
Active strength: 160 mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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: Humco Calamine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	160 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
f7dcd959-fb98-43bb-8dd3-a662bf8a053c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-0413-96	Humco Calamine	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-0413-96	ML - Milliliter	0395-0413	7388d9e7-558f-47b8-9386-b0372be86ab3	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]	1
CALCIUM HYDROXIDE	INACTIVE INGREDIENT	PF5DZW74VN	HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-0413	HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20231216_f7dcd959-fb98-43bb-8dd3-a662bf8a053c.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 59 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Astonea Skin Protectant	ZINC OXIDE	ASTONEA LABS PRIVATE LIMITED	e3c7a515-3e77-da85-e053-2995a90a3ee1	2024-06-25	Warnings	Exact identifier application number: M016
Astonea Vitamin A and D	WHITE PETROLATUM	ASTONEA LABS PRIVATE LIMITED	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2024-06-25	Warnings	Exact identifier application number: M016
ZOEY NATURALS DIAPER Cream	ZINC OXIDE	Absolutely Natural	70fac4d6-8833-4799-b6b6-796f8f13f80e	2024-06-25	Warnings	Exact identifier application number: M016
Medicated Body	MENTHOL AND ZINC OXIDE	Universal Distribution Center LLC	2a59a847-cc7a-42cf-b49a-92e7254c1629	2024-06-19	Warnings	Exact identifier application number: M016
THERA Moisturizing Body Shield	DIMETHICONE	McKesson Medical-Surgical Inc.	56869b64-11ee-4df6-8102-ce5818e0116e	2024-06-18	Warnings	Exact identifier application number: M016
Dimethicone	SKIN PROTECTANT	McKesson	96886b33-44d4-5a2a-e053-2a95a90a505e	2024-06-18	Warnings	Exact identifier application number: M016
Derma E Eczema Relief	OATMEAL	derma e	767c4a76-8ccb-4530-9b4b-a7ea1a596c7f	2024-06-18	Warnings	Exact identifier application number: M016
Insect sting relief pad 01	SODIUM BICARBONATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	1b0f0088-6482-6de7-e063-6294a90aeeb7	2024-06-17	Warnings	Exact identifier application number: M016
THERA Calazinc Body Shield	ZINC OXIDE	McKesson Medical-Surgical Inc.	974b1046-83ee-4207-91d3-40982beb9c63	2024-06-17	Warnings	Exact identifier application number: M016
Dimethicone	BODY CLEANSER	McKesson	8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8	2024-06-14	Warnings	Exact identifier application number: M016
Dr. Mom Butt Balm	DIMETHICONE PETROLATUM	Ferndale Laboratories, Inc.	ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd	2024-06-13	Warnings	Exact identifier application number: M016
Secura Protective	PETROLATUM	Smith & Nephew Medical Ltd	20906566-fbf2-46d9-a5d8-c7f7356d1080	2024-06-12	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	NuCare Pharmaceuticals,Inc.	66e98554-e158-a519-e053-2a91aa0a6783	2024-06-06	Warnings, Adverse reactions	Exact identifier application number: M016
CVS Health Vitamin A and D Skin Protectant	LANOLIN AND PETROLATUM	CVS Health	fe3ccabb-9644-4091-9dca-ffd96a43ecaf	2024-05-28	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	186a9642-cd73-adfb-e063-6394a90a75c7	2024-05-14	Warnings	Exact identifier application number: M016
Honest Eczema Balm	COLLOIDAL OATMEAL	The Honest Company, Inc.	35b8bc5c-420e-4d31-9659-f36cabbd897a	2024-05-14	Warnings	Exact identifier application number: M016
Extra Strength Itch Stopping	ITCH STOPPING CREAM	Universal Distribution Centre LLC	b9a42aa3-1903-76f0-e053-2a95a90a51d1	2024-05-13	Warnings	Exact identifier application number: M016
Calamine Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Cardinal Health, 110 dba Leader	7f733c0a-82b2-d3b0-e053-2991aa0a6b0f	2024-05-13	Warnings	Exact identifier application number: M016
Walgreens Maximum Diaper Rash	ZINC OXIDE	Walgreens Company	5eb2152f-6fa2-4191-878a-207416e69818	2024-05-07	Warnings	Exact identifier application number: M016
Cetaphil Eczema Rapid Relief Cream	COLLOIDAL OATMEAL	Galderma Laboratories, L.P.	02a405fa-8ae9-41e9-b86f-ef5fb6e3844a	2024-05-02	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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	f7dcd959-fb98-43bb-8dd3-a662bf8a053c	8
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	f7dcd959-fb98-43bb-8dd3-a662bf8a053c	8
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	f7dcd959-fb98-43bb-8dd3-a662bf8a053c	8
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	f7dcd959-fb98-43bb-8dd3-a662bf8a053c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0395-0413-96	00395041396	177 mL in 1 BOTTLE, PLASTIC (0395-0413-96)	177 ml	2017-11-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Humco Calamine Lotion	Humco holding Group, Inc. \| Pharma Nobis, LLC	2026-05-26	HUMAN OTC DRUG LABEL	8