FDA.reportPublic FDA data

Sunmark Caldyphen Clear

Product NDC
49348-610
11-digit product format
493480610
Labeler code
49348
Product ID
49348-610_0ce5bdec-f4fe-73d9-e063-6294a90a6a87
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Acetate and Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-25
Substance
PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
10; 80 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

Additional Listing Data#

Finished product
Yes
Brand name base
Sunmark Caldyphen Clear
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE80 mg/mL
PRAMOXINE HYDROCHLORIDE10 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
88AYB867L5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
329cd4ef-b699-46ff-a5d6-907f7c327c03Available 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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-610-36Sunmark Caldyphen Clear177 mL in 1 BOTTLE, PLASTICLOTION1776

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-610-36ML - Milliliter49348-61000f00bc9-a5c2-4961-afe7-42bc54dd0e2412014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5SUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
PRAMOXINEACTIVE MOIETY068X84E056SUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
ZINC CATIONACTIVE MOIETY13S1S8SF37SUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941SUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4SUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-610SUNMARK CALDYPHEN CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [STRATEGIC SOURCING SERVICES LLC]6Current NDC, Legacy NDC, 1 package rows20231220_329cd4ef-b699-46ff-a5d6-907f7c327c03.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 1 of 71 · 1,410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-610-3649348061036177 mL in 1 BOTTLE, PLASTIC (49348-610-36) 177 ml2017-12-120000-00-00NoNoCurrent