calahist clear

Product NDC
0363-9412
11-digit product format
003639412
Labeler code
0363
Product ID
0363-9412_07cc6f4e-56d6-fa89-e063-6294a90abcad
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine hydrochloride and Zinc acetate
Dosage form
LOTION
Route
TOPICAL
Labeler
WALGREEN COMPANY
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-16
Substance
PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength
10; 1 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
calahist clear
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC ACETATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5, FM5526K07A
Rxcui1234546

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
0363-9412-97calahist clear177 mL in 1 BOTTLELOTION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9412CALAHIST CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [WALGREEN COMPANY]2Current NDC, 1 package rows20231030_fed469c2-fe13-6726-e053-6394a90a5f51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSNfed469c2-fe13-6726-e053-6394a90a5f512
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCDfed469c2-fe13-6726-e053-6394a90a5f512
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSYfed469c2-fe13-6726-e053-6394a90a5f512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9412-9700363941297177 mL in 1 BOTTLE (0363-9412-97) 177 ml2023-10-16NoNoHistorical