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
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC OXIDE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5, SOI2LOH54Z

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

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