Calamine Phenolated Topical Suspension

Product NDC: 0395-0407
11-digit product format: 003950407
Labeler code: 0395
Product ID: 0395-0407_0c92d58b-b1c7-dc2c-e063-6394a90a4d7a
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine and Zinc Oxide and Phenol
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; PHENOL
Active strength: 160; 10 mg/mL; 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: Calamine Phenolated Topical Suspension
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	160 mg/mL
PHENOL	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
339NCG44TV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
991369	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
a3816729-be2b-4b4f-a609-953576cd2e3b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-0407-96	Calamine Phenolated Topical Suspension	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-0407-96	ML - Milliliter	0395-0407	6a929f43-d6bc-4088-b8db-caceb25c92a1	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENOL	ACTIVE INGREDIENT	339NCG44TV	CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC]	1
PHENOL	ACTIVE MOIETY	339NCG44TV	CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC]	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC]	1
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC]	1
CALCIUM HYDROXIDE	INACTIVE INGREDIENT	PF5DZW74VN	CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-0407	CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC]	6	Current NDC, Legacy NDC, 1 package rows	20231216_a3816729-be2b-4b4f-a609-953576cd2e3b.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 18 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Skin Mercy Recovery Cream	COLLOIDAL OATMEAL	Cultskin Apothecary, Inc.	4bac19f3-13bb-8d18-e063-6394a90aa393	2026-02-25	Warnings	Exact identifier application number: M016
Skin Mercy Intense Recovery Cream	COLLOIDAL OATMEAL	Cultskin Apothecary, Inc.	468f21c6-2d6f-1654-e063-6394a90ab2f5	2026-02-25	Warnings	Exact identifier application number: M016
Magnet Eye Sheet Mask	EYE MASK	Guangdong Bisutang Biotechnology Co., LTD	4a0a84d4-4024-5ea7-e063-6394a90a2b6c	2026-02-24	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Family Dollar Stores, Inc	ac7da793-8a39-4b47-b075-a4c4820cadad	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Family Dollar Stores, Inc	1a03331e-3676-451c-be22-9a547e8ae6e2	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Family Dollar Stores, Inc	7e64a424-afdb-4eb9-b6af-7b8123f1e207	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	H E B	e6154e44-d7b2-429c-9bc7-5c064220d3fb	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	H E B	f0b31d52-2903-487a-aa70-0dbdf4c4d7e7	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	H E B	ff79e42c-da3f-4aec-acf4-cc26e10a1d08	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	H E B	a8ad595a-c811-4534-82e0-9a01085b4b1e	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	H E B	ce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	H E B	460802cc-c1b9-41cb-afe3-ca4078175efb	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	H E B	2dd85211-0840-4d0d-8ba7-ea6184a50942	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Meijer, Inc.	12867b23-b203-4bd7-af6d-efddeead26be	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	Meijer, Inc.	c7a4b7f2-4de9-470c-9f5b-0142bd935137	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Better Living Brands, LLC	75cb8f17-6ef2-403e-ab6e-d8e1e8168ec8	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M016
WHITE PETROLATUM	PETROLATUM	Sion Biotext Medical Ltd	53ca3aeb-1d5d-4964-adb5-1cfa901642da	2026-02-23	Warnings	Exact identifier application number: M016
Clear Anti Itch	PRAMOXINE HCL, ZINC ACETATE	Better Living Brands, LLC	1d491635-9605-44fa-9860-ea23e4e8b21c	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Better Living Brands, LLC	ba50f2b2-aff8-42cd-8af0-369060a901fb	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M016
Oatmeal	DIMETHICONE	Better Living Brands, LLC	d28c5a60-0597-424f-bf7f-08dca39b22f5	2026-02-23	Warnings, Adverse reactions	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
339NCG44TV	PHENOL	108-95-2	PHENOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991369	calamine 8 % / phenol 1 % / zinc oxide 8 % Topical Lotion	PSN	a3816729-be2b-4b4f-a609-953576cd2e3b	6
991369	calamine 80 MG/ML / phenol 10 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	a3816729-be2b-4b4f-a609-953576cd2e3b	6
991369	calamine 8 % / phenol 1 % / zinc oxide 8 % Topical Lotion	SY	a3816729-be2b-4b4f-a609-953576cd2e3b	6
991369	calamine 8 % / phenol 1 % / zinc oxide 8 % Topical Suspension	SY	a3816729-be2b-4b4f-a609-953576cd2e3b	6
991369	Calamine 80 MG/ML / phenol 10 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	a3816729-be2b-4b4f-a609-953576cd2e3b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0395-0407-96	00395040796	177 mL in 1 BOTTLE, PLASTIC (0395-0407-96)	177 ml	2017-11-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Calamine PhenolatedTopical Suspension USP	Humco Holding Group, Inc \| Pharma Nobis, LLC	2023-12-15	HUMAN OTC DRUG LABEL	6