FDA.reportPublic FDA data

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
IngredientStrength
ZINC OXIDE160 mg/mL
PHENOL10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
339NCG44TVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
991369Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e68efc4-4c95-41c0-9fed-32297b1b2edcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-802-34Sunmark Phenolated Calamine177 mL in 1 BOTTLE, PLASTICLOTION1776

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-802-34ML - Milliliter49348-80247daa58c-0286-451e-a515-aa3ddcd39ac512014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOLACTIVE INGREDIENT339NCG44TVSUNMARK PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [MCKESSON]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSUNMARK PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [MCKESSON]1
PHENOLACTIVE MOIETY339NCG44TVSUNMARK PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [MCKESSON]1
ZINC CATIONACTIVE MOIETY13S1S8SF37SUNMARK PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [MCKESSON]1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CSUNMARK PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [MCKESSON]1
CALCIUM HYDROXIDEINACTIVE INGREDIENTPF5DZW74VNSUNMARK PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [MCKESSON]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUNMARK PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [MCKESSON]1
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-802SUNMARK PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [STRATEGIC SOURCING SERVICES LLC]6Current NDC, Legacy NDC, 1 package rows20231220_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 33 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XIMONTH Bee Venom Wart Remover PatchGLYCERINShantou Ximonth Biotechnology Co., Ltd.3e6965b6-8f08-db62-e063-6394a90a64c92025-11-26WarningsExact identifier
application number: M016
XIMONTH GLP-1 PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.3d03cdfd-2e9e-f9a1-e063-6394a90a6a8b2025-11-26WarningsExact identifier
application number: M016
XIMONTH Bee Venom RepairGLYCERINShantou Ximonth Biotechnology Co., Ltd.37e40cc1-1121-1eee-e063-6294a90aab262025-11-26WarningsExact identifier
application number: M016
XIMONTH Liquid Wart Corn Callus RemoverGLYCERINShantou Ximonth Biotechnology Co., Ltd.3a1b872a-2883-0b70-e063-6294a90af9d62025-11-26WarningsExact identifier
application number: M016
XIMONTH Jimerito Honey For EyesGLYCERINShantou Ximonth Biotechnology Co., Ltd.3aa38704-4d2b-ffaf-e063-6294a90a323e2025-11-26WarningsExact identifier
application number: M016
XIMONTH Bee Honey Eye DropsGLYCERINShantou Ximonth Biotechnology Co., Ltd.3e69c950-bbbc-5c47-e063-6294a90a070e2025-11-26WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.4c7e832e-55f3-4766-98b7-29b17d741a4b2025-11-26WarningsExact identifier
application number: M016
Vitamin A DVITAMIN A DHenry Scheineb00264f-e73d-771b-e053-2a95a90a85e52025-11-25WarningsExact identifier
application number: M016
Leader Baby Skin ProtectantBABY SKIN PROTECTANTCardinal Healthb83ee0e1-d1a3-6c4a-e053-2a95a90aec392025-11-25WarningsExact identifier
application number: M016
LDR Vitamans A and DVITAMINS A AND D OINTMENTCardinal Health77801bfb-43dc-cdca-e053-2991aa0a3f342025-11-25WarningsExact identifier
application number: M016
Zinc Oxide 40%DIAPER RASH SKIN PROTECTENTCardinal Health80c24e21-6aba-0c05-e053-2a91aa0a657f2025-11-25WarningsExact identifier
application number: M016
Skin ProtectantZINC OXIDE 25%Cardinal Health8abda4ad-2ef7-9428-e053-2a95a90ac0fb2025-11-25WarningsExact identifier
application number: M016
Rugby Zinc Oxide 20%RUGBY ZINC OXIDE 20%Rugby Laboratoriesb96f6697-c912-7d62-e053-2a95a90a9f5b2025-11-25WarningsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMHenry Scheineb7a5698-754e-4e46-e053-2a95a90a57b42025-11-25WarningsExact identifier
application number: M016
White PetrolatumSKIN PROTECTANTCardinal Health8b381857-6f58-177e-e053-2995a90aa8c92025-11-25WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC43edc287-57e1-d96e-e063-6294a90ac5a12025-11-24WarningsExact identifier
application number: M016
Cetaphil Soothing Gel CreamALLANTOINGalderma Laboratories, L.P.bab404f0-2f7a-4bac-b053-cbdc81c029b52025-11-24WarningsExact identifier
application number: M016
health beyond VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.de87da51-cf92-402c-b60f-5f28d17241242025-11-23WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP00766a7b-797e-dd15-e063-6394a90af9ac2025-11-20WarningsExact identifier
application number: M016
Itch Eraser SensitiveSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands2250525a-45c2-42ea-e063-6394a90ac0012025-11-18WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical LotionPSN8e68efc4-4c95-41c0-9fed-32297b1b2edc6
991369calamine 80 MG/ML / phenol 10 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD8e68efc4-4c95-41c0-9fed-32297b1b2edc6
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical LotionSY8e68efc4-4c95-41c0-9fed-32297b1b2edc6
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical SuspensionSY8e68efc4-4c95-41c0-9fed-32297b1b2edc6
991369Calamine 80 MG/ML / phenol 10 MG/ML / ZNO 80 MG/ML Topical LotionSY8e68efc4-4c95-41c0-9fed-32297b1b2edc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-802-3449348080234177 mL in 1 BOTTLE, PLASTIC (49348-802-34) 177 ml2017-12-120000-00-00NoNoCurrent