calahist

Product NDC
0363-9411
11-digit product format
003639411
Labeler code
0363
Product ID
0363-9411_079d3e20-150d-ce65-e063-6294a90af07f
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine and Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
WALGREEN COMPANY
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-16
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
calahist
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
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
0363-9411-97calahist177 mL in 1 BOTTLELOTION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9411CALAHIST (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [WALGREEN COMPANY]2Current NDC, 1 package rows20231030_fed45e06-cc53-fbc5-e053-6294a90a1b19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSNfed45e06-cc53-fbc5-e053-6294a90a1b192
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCDfed45e06-cc53-fbc5-e053-6294a90a1b192
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSYfed45e06-cc53-fbc5-e053-6294a90a1b192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9411-9700363941197177 mL in 1 BOTTLE (0363-9411-97) 177 ml2023-10-16NoNoHistorical