FDA.reportPublic FDA data

Sunmark Caldiphen

Product NDC
49348-337
11-digit product format
493480337
Labeler code
49348
Product ID
49348-337_0ec0504c-907b-15fa-e063-6294a90a871f
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine and Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Strategic Sourcing Services
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 Caldiphen
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
Rxcui1234532

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
49348-337-36Sunmark Caldiphen177 mL in 1 BOTTLE, PLASTICLOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-337SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [STRATEGIC SOURCING SERVICES]5Current NDC, Legacy NDC, 1 package rows20240113_4f4d4c54-64b5-4e20-bed0-c7fb470b8434.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN4f4d4c54-64b5-4e20-bed0-c7fb470b84345
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD4f4d4c54-64b5-4e20-bed0-c7fb470b84345
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY4f4d4c54-64b5-4e20-bed0-c7fb470b84345

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-337-3649348033736177 mL in 1 BOTTLE, PLASTIC (49348-337-36) 177 ml2014-04-020000-00-00NoNoCurrent