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 9 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
application number: M016
BABY BUM DIAPERZINC OXIDECreative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare53d8a654-aaec-6f91-e063-6394a90a73512026-06-09WarningsExact identifier
application number: M016
CELISTAR MICRONEEDLING INFUSIONHYALURONATE SODIUMGuangdong Outeli Biotechnology Co., Ltd.53de46a7-3947-70a7-e063-6294a90ab8292026-06-09WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
application number: M016
WOODSLEEP Wild Yam CreamGLYCERINShantou Woodsleep Biotechnology Co., Ltd.53b992fd-5759-57bb-e063-6394a90a16002026-06-08WarningsExact identifier
application number: M016
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
application number: M016
GNP Calamine Topical SuspensionCALAMINE 8% AND ZINC OXIDE 8%Amerisource Bergen777b0e66-1bce-4483-9dad-c46796fd6f232026-06-04WarningsExact identifier
application number: M016
GNP CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEAmerisource Bergen515c58d7-0dc4-45e7-9155-e5270a16290e2026-06-04WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company535a0e8e-6bb4-6652-e063-6394a90aa7ff2026-06-03WarningsExact identifier
application number: M016
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.535e42a1-8b14-324d-e063-6394a90a3f652026-06-03WarningsExact identifier
application number: M016
Petroleum Jelly Skin ProtectantWHITE PETROLATUMAcme United Corporation535e94bb-21e8-90be-e063-6394a90a37bb2026-06-03WarningsExact identifier
application number: M016
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
application number: M016
PUTRIZEN 40 UREAGLYCERINShantou Ximonth Biotechnology Co., Ltd.533dadbc-6f20-d880-e063-6394a90a753f2026-06-01WarningsExact identifier
application number: M016
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
application number: M016
KIEHLS SINCE 1851 Ultra Facial Meltdown RecoveryCOLLOIDAL OATMEALLOreal USA Products Inc22e088b9-b3b1-4c34-be12-a5a31200ec252026-05-29WarningsExact identifier
application number: M016
Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.53008b89-89ab-7650-e063-6294a90ac16c2026-05-29WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
application number: M016
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact 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