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 43 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum JellyWHITE PETROLATUM JELLYWALGREENS1fc9eecd-fd25-827c-e063-6394a90a26a52025-03-26WarningsExact identifier
application number: M016
Cocoa Butter Petroleum JellyWHITE PETROLATUM JELLYWALGREENS1fcc9626-6058-e9b3-e063-6394a90ab5252025-03-26WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD313b08e2-d764-96da-e063-6294a90ab7052025-03-25WarningsExact identifier
application number: M016
Eczema CreamECZEMA CREAMKyte Baby LLC30c943aa-d9dc-5c16-e063-6294a90a3c582025-03-20WarningsExact identifier
application number: M016
Koala Kubs Diaper Rash CreamDIAPER RASH CREAMMelaleuca, Inc.c6b3b0dd-22a8-16f7-e053-2a95a90a51ea2025-03-20WarningsExact identifier
application number: M016
Gold Bond Eczema Relief Medicated Skin Protectant CreamCOLLOIDAL OATMEALChattem, Inc.2b6b8342-878d-4588-8b24-6746d35d319d2025-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy PeachCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company30b20bd5-3b4f-8cc7-e063-6394a90a91062025-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh StrawberryCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company30b2744d-fb59-f383-e063-6294a90abd2a2025-03-19WarningsExact identifier
application number: M016
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
application number: M016
Gold Bond Diabetics Medicated Dry Skin Relief Foot CreamDIMETHICONE, WHITE PETROLATUMChattem, Inc.b951d1cb-b81e-4d7f-9a67-8405daa896672025-03-19WarningsExact identifier
application number: M016
Gold Bond Eczema Relief Medicated Hand CreamCOLLOIDAL OATMEALChattem, Inc.27457bc5-3edc-4c8b-b8a2-eaf09b511cf82025-03-19WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD30a977c3-6862-670e-e063-6294a90aeb2f2025-03-18WarningsExact identifier
application number: M016
YVTYVT Copper Peptides Face SerumCOPPER TRIPEPTIDE-1Beijing JUNGE Technology Co., Ltd.306f2d48-43b8-359a-e063-6394a90a06dc2025-03-16Boxed warning, WarningsExact identifier
application number: M016
Dr Talbots Cooling Perineal PadWATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATETalbot's Pharmaceuticals family Products, LLC.242277e2-ff26-ad4e-e063-6394a90ab3172025-03-14WarningsExact identifier
application number: M016
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
application number: M016
Aavini Double Layer Brightening Spot Correcting Essence OilAAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OILQingyuan Moksha Biotechnology Co., Ltd.2ff89a13-3969-2df1-e063-6394a90ac0d32025-03-10WarningsExact identifier
application number: M016
5% Signature Numb cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3008bbeb-abba-5cdb-e063-6294a90ae4832025-03-10WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber MelonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2fc4745c-fac9-7861-e063-6294a90a3f142025-03-07WarningsExact identifier
application number: M016
AD Skin ProtectantAD SKIN PROTECTANTWellSpring Pharmaceutical Corporationd26f1312-2e1b-4106-bc48-a336d4e034ad2025-03-07WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Nighttime BalmOATMEALKenvue Brands LLC04d90e45-c2ee-4122-b919-a0eb6d11b59a2025-03-04WarningsExact 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