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 56 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ECZEMA	OATMEAL	ORGANIC & SUSTAINABLE BEAUTY	81eb3df4-5beb-45aa-82ca-e8b4b37e45f4	2024-11-05	Warnings, Adverse reactions	Exact identifier application number: M016
Aveeno Baby Calming Comfort	DIMETHICONE	Kenvue Brands LLC	567b1481-b783-45f9-af38-5630c9edf044	2024-11-01	Warnings	Exact identifier application number: M016
ZO Skin Health Astringent Solution	ALUMINUM ACETATE	ZO Skin Health, Inc.	cb801d7e-52ad-6c16-e053-2a95a90a7a1f	2024-10-31	Warnings	Exact identifier application number: M016
ZINC OXIDE PHARMA	ZINC OXIDE	ALLIED TRADE LINK LLC	1b580bf6-f217-5c0f-e063-6294a90a012e	2024-10-29	Warnings	Exact identifier application number: M016
Dove DermaSeries Eczema Relief Soothing Body	COLLOIDAL OATMEAL	Conopco, Inc. d/b/a/ Unilever	59f737f6-dd3f-4b63-b13e-2345cb9a951a	2024-10-24	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER SHEA BUTTER	Conopco Inc. d/b/a/ Unilever	a735d885-bacd-0f5c-e053-2a95a90ad14a	2024-10-24	Warnings	Exact identifier application number: M016
Baby Dove	8H MOISTURIZATION HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	b8dc481c-1ac3-2d63-e053-2a95a90a44f5	2024-10-24	Warnings	Exact identifier application number: M016
Vaseline	CLINICAL CARE HAND SANITIZER LOTION	Conopco Inc. d/b/a/ Unilever	ba0aa323-8887-597f-e053-2995a90a2077	2024-10-24	Warnings	Exact identifier application number: M016
Dove	NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION	Conopco Inc. d/b/a/ Unilever	d1039316-3ca8-90f8-e053-2995a90a2061	2024-10-24	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER LAVENDER	Conopco Inc. d/b/a/ Unilever	a736838b-b559-f066-e053-2995a90a90f5	2024-10-24	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	Rejoice International Corp.	130d94d8-ad98-d61f-e063-6294a90a76b0	2024-10-21	Warnings	Exact identifier application number: M016
HARMON DAILY MOISTURZIER	DIMETHICONE	HARMON STORES, INC.	bda5dbaa-5d62-4a40-ba55-e2066e8ca1c7	2024-10-21	Warnings	Exact identifier application number: M016
Dimethicone	BODY SHIELD	McKesson	8febb45d-a200-702c-e053-2995a90a3e62	2024-10-18	Warnings	Exact identifier application number: M016
PETROLEUM	WHITE PETROLATUM	VIVE HEALTH LLC	24ae3875-1c86-c7ba-e063-6394a90a6729	2024-10-17	Warnings	Exact identifier application number: M016
Meijer Skin Relieving Moisturizing	DIMETHICONE	MEIJER DISTRIBUTION, INC	8e5be6b3-87e7-d958-e053-2a95a90a6961	2024-10-16	Warnings	Exact identifier application number: M016
GenRx Daily Defense Skin Repairing	DIMETHICONE	PureTek Corporation	7d2827fd-b40f-454b-bb60-54d77823b18c	2024-10-16	Warnings	Exact identifier application number: M016
Equate Daily Moisturizing Dimethicone Skin Protectant	DIMETHICONE	Walmart Stores Inc.	8fda01f7-a52a-4a63-98ac-b32cb47947f3	2024-10-16	Warnings	Exact identifier application number: M016
Hill Country Essentials	DIMETHICONE	H.E.B	c51d8647-8af6-473a-b989-dfa6bfdc368d	2024-10-15	Warnings	Exact identifier application number: M016
UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED	WHITE PETROLEUM	Universal Distribution Center LLC	649e571f-0cd6-41e4-b31f-c818f94fb01d	2024-10-15	Warnings	Exact identifier application number: M016
WALGREENS ECZEMA	COLLOIDAL OATMEAL	WALGREEN COMPANY	fc502963-4cb6-5ce5-e053-6394a90a58c3	2024-10-14	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
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