Sunmark Phenolated Calamine

Product NDC: 49348-802
Requested package NDC: 49348-802-34
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: 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: Sunmark Phenolated Calamine
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
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 41 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terrasil Infection Protection Wound Care	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	e98d1d8c-c979-49de-9bd8-cd409efff6de	2025-07-11	Warnings	Exact identifier application number: M016
Neosporin Lip Health Overnight Renewal Therapy	PETROLATUM	Kenvue Brands LLC	0da54fe1-c99f-4a2d-9ee5-2dc24005096c	2025-07-10	Warnings	Exact identifier application number: M016
COCOA BUTTER PETROLEUM jelly	PETROLATUM	Savvy Care & Cosmetics Pvt. Ltd.	397d13f1-3b86-3c76-e063-6394a90a0f24	2025-07-09	Warnings	Exact identifier application number: M016
Pipette Eczema	COLLOIDAL OATMEAL	Pipette LLC	39829827-d801-f5a7-e063-6394a90a024c	2025-07-09	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Westminster Pharmaceuticals, LLC	7e045b3a-f33b-4faa-ab9b-2baec6ff7924	2025-07-08	Warnings	Exact identifier application number: M016
Desitin Multi-Purpose Healing	PETROLATUM	Kenvue Brands LLC	30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab	2025-07-07	Warnings	Exact identifier application number: M016
Astringent Solution	ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE	First Nation Group	065c895c-7d86-f1ed-e063-6394a90a3a52	2025-07-07	Warnings	Exact identifier application number: M016
Creamy Petroleum	PETROLATUM	Savvy Care & Cosmetics Pvt Ltd	3916daee-f8d2-e3f0-e063-6294a90a3883	2025-07-04	Warnings	Exact identifier application number: M016
Exemax Cream	DIMETHICONE, ALLANTOIN	PureTek Corporation	38e79055-df84-d314-e063-6394a90ac95f	2025-07-01	Warnings	Exact identifier application number: M016
Procure Dimethicone 5%	DIMETHICONE	Twin Med LLC	38a7e4af-997d-549e-e063-6394a90a0bd6	2025-06-28	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE OINTMENT	Derma Sciences Canada Inc.	37eff762-1ea9-ec66-e063-6394a90a3d10	2025-06-19	Warnings	Exact identifier application number: M016
Dr.Johnes SKIN TAG REMOVER	SALICYLIC ACID	Dr.Johnes LLC	b731c55e-31ee-429f-8432-fac7c5718d83	2025-06-18	Warnings	Exact identifier application number: M016
Dr. Johne SKIN TAG REMOVER	SALICYLIC ACID	Dr.Johnes LLC	6c5adc3c-9d45-449a-ad42-f9571851cd18	2025-06-18	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal	OATMEAL	THERAPLEX, LLC	e51aa467-ffe7-4c6b-8588-6df8592596d4	2025-06-16	Warnings	Exact identifier application number: M016
ZIIDII Wild Yam Cream	WILD YAM	Guangzhou Haishi Biological Technology Co., Ltd.	3733154a-4884-9988-e063-6294a90aa78c	2025-06-10	Warnings	Exact identifier application number: M016
Aveeno Calm Plus Restore Skin Therapy Balm	COLLOIDAL OATMEAL	Kenvue Brands LLC	dbe7a2cc-9c21-2a48-e053-2a95a90a54e2	2025-06-04	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	WALGREENS	2017113f-d192-5fbb-e063-6294a90a83b0	2025-05-31	Warnings	Exact identifier application number: M016
AHHH Bite Relief	SODIUM BICARBONATE	78271	25a1e070-9228-4ec9-e063-6294a90ad78d	2025-05-27	Warnings	Exact identifier application number: M016
SupreH Bee Venom Skin Tag Treatment Liquid	SUPREH BEE VENOM SKIN TAG REMOVER LIQUID	Shenzhen Xinxin Yunhai Technology Co., Ltd.	35ca9836-917a-b0ac-e063-6294a90a28a2	2025-05-23	Warnings	Exact identifier application number: M016
terrasil Diabetics Ulcer and Bed Sore Relief	ALLANTOIN	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	35d2738c-dacf-7309-e063-6294a90aab4c	2025-05-23	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