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 23 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Pure petroleum	WHITE PETROLATUM	Rite Aid Corporation	f67be4cc-9983-4758-93c8-383919ec07ca	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Rite Aid Corporation	0d535736-ba61-42eb-9112-c154295372a2	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	ec67a1ee-ad71-54f2-e053-2995a90a7690	2026-01-29	Warnings	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	7-Select	7e93df71-74bd-4d95-9a64-54756c7b234a	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016
TheraCare Diabetic Foot Cream	DIMETHICONE, PETROLATUM	Veridian Healthcare	49132a75-4a16-cede-e063-6294a90a6217	2026-01-29	Warnings	Exact identifier application number: M016
TheraCare A and D	LANOLIN, PETROLATUM	Veridian Healthcare	1303aa33-2111-b36c-e063-6294a90af131	2026-01-29	Warnings	Exact identifier application number: M016
Zinc oxide	ZINC OXIDE	Aldi, Inc	d56782c1-b23c-47a9-82cb-d7dbb0ac7aa3	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Aldi, Inc	94fea2f2-fea8-4923-afc6-36068bc2fef5	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016
DAILY MOISTURIZING	DIMETHICONE LOTION	Aldi, Inc	4ad18f4a-e148-4bf5-a04b-4168fa48eeb2	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Aldi, Inc	79f498af-c207-4f85-bf1b-fb2ee8379fd8	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE	AMERISOURCE BERGEN	90d9d908-57ea-4062-ade0-8a4888939c91	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	066b1313-aed8-9436-e063-6294a90a2b11	2026-01-29	Warnings	Exact identifier application number: M016
Equate Scar Topical	ALLANTOIN	WalMart	cf511a02-355c-4286-82fa-6f0c4a244823	2026-01-29	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