Sunmark Phenolated Calamine

Product NDC: 49348-802
11-digit product format: 493480802
Labeler code: 49348
Product ID: 49348-802_0ce5c95c-a899-9b32-e063-6294a90a86b9
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine and Zinc Oxide and Phenol
Dosage form: LOTION
Route: TOPICAL
Labeler: Strategic Sourcing Services LLC
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: 2026-12-31
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: Sunmark Phenolated Calamine
Listing expiration: 2026-12-31

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
8e68efc4-4c95-41c0-9fed-32297b1b2edc	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
49348-802-34	Sunmark Phenolated Calamine	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
49348-802-34	ML - Milliliter	49348-802	47daa58c-0286-451e-a515-aa3ddcd39ac5	1	2014-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-802	SUNMARK PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [STRATEGIC SOURCING SERVICES LLC]	6	Current NDC, Legacy NDC, 1 package rows	20231220_8e68efc4-4c95-41c0-9fed-32297b1b2edc.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 49 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Savvy Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE	Savvy Care and Cosmetics	05ee2662-6a51-6e49-e063-6294a90a4ed7	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Lavender Baby Petroleum	WHITE PETROLEUM	Home Smart Products	5828df37-2a42-4129-8e4e-d5ac9c4c9615	2024-12-19	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	980d030a-feaf-4a81-865e-f85c66151380	2024-12-19	Warnings	Exact identifier application number: M016
Baby Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	caf568aa-3889-41ff-835e-875bb6d9ca79	2024-12-19	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	a45eb8aa-9fc9-4332-a3ef-0e6fd348fb95	2024-12-19	Warnings	Exact identifier application number: M016
Cars Petroleum	WHITE PETROLATUM	Ultra Distributors Inc.	9905b5a4-382e-4d2a-b971-37998c14c330	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Aloe Vera Petroleum	WHITE PETROLEUM	Home Smart Products	2671f2ed-af9d-4234-95bf-def368242a78	2024-12-19	Warnings	Exact identifier application number: M016
DCH Scar	ALLANTOIN 0.5%	Derma Care Research Labs, LLC	00edbc64-9d32-5751-e063-6294a90a400b	2024-12-19	Warnings	Exact identifier application number: M016
Bamboobies Diaper Rash	ZINC OXIDE 15%	Derma Care Research Labs, LLC	0411f5e3-03d2-c512-e063-6394a90a37d3	2024-12-19	Warnings	Exact identifier application number: M016
Maximum Strength Medicated Foot Powder	MEDICATED FOOT POWDER	Jell Pharmaceuticals Pvt. Ltd.	cdaae985-5363-e9d2-e053-2995a90a2682	2024-12-18	Warnings	Exact identifier application number: M016
BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Jell Pharmaceuticals Pvt Ltd.	d80d21cf-9463-7184-e053-2995a90a23f3	2024-12-18	Warnings	Exact identifier application number: M016
Health Smart Baby Petroleum	WHITE PETROLEUM	Home Smart Products	edd9d018-c2c9-4a9a-b727-0a92cd463c02	2024-12-18	Warnings	Exact identifier application number: M016
Health Smart Cocoa Butter Petroleum	WHITE PETROLEUM	Home Smart Products	a65c8267-d34f-4542-a7ca-5180e860a03d	2024-12-18	Warnings	Exact identifier application number: M016
Princess Petroleum	WHITE PETROLATUM	Ultra Distributors Inc.	6d9c92bf-9263-40a4-acac-5c3f0b08c69d	2024-12-18	Warnings	Exact identifier application number: M016
Meijer Petroleum Jelly	WHITE PETROLATUM	Meijer Distribution, Inc	b299cf2a-2c6a-68f4-e053-2995a90a5bd7	2024-12-18	Warnings	Exact identifier application number: M016
Foster and Thrive Caldyphen	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	29945734-4ea6-b702-e063-6294a90ae6f2	2024-12-18	Warnings	Exact identifier application number: M016
Foster and Thrive Caldyphen Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Strategic Sourcing Services, LLC	29946912-9794-8a8e-e063-6394a90a279e	2024-12-18	Warnings	Exact identifier application number: M016
Caring Mills Petroleum Jelly	WHITE PETROLATUM	Veridian Healthcare	fbbfa780-0e2b-1874-e053-6394a90a5eeb	2024-12-18	Warnings	Exact identifier application number: M016
Serawise Eczema Rescue	OATMEAL	DrAnaMaria.com LLC	e805866a-2349-4b86-bc83-a7c859cb9403	2024-12-18	Warnings	Exact identifier application number: M016
TheraCare Petroleum Jelly	WHITE PETROLATUM	Veridian Healthcare	d6fad49b-8a49-7f7c-e053-2a95a90ae638	2024-12-18	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	8e68efc4-4c95-41c0-9fed-32297b1b2edc	6
991369	calamine 80 MG/ML / phenol 10 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	8e68efc4-4c95-41c0-9fed-32297b1b2edc	6
991369	calamine 8 % / phenol 1 % / zinc oxide 8 % Topical Lotion	SY	8e68efc4-4c95-41c0-9fed-32297b1b2edc	6
991369	calamine 8 % / phenol 1 % / zinc oxide 8 % Topical Suspension	SY	8e68efc4-4c95-41c0-9fed-32297b1b2edc	6
991369	Calamine 80 MG/ML / phenol 10 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	8e68efc4-4c95-41c0-9fed-32297b1b2edc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-802-34	49348080234	177 mL in 1 BOTTLE, PLASTIC (49348-802-34)	177 ml	2017-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunmark Phenolated Calamine Lotion USP	Strategic Sourcing Services LLC \| Pharma Nobis, LLC	2023-12-19	HUMAN OTC DRUG LABEL	6