FDA.reportPublic FDA data

Calamine Plus Pramoxine HCl

Product NDC
0363-8588
11-digit product format
003638588
Labeler code
0363
Product ID
0363-8588_42f4d18a-ecba-3154-e063-6394a90afe80
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine Plus No-Touch
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Walgreens Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-12
Substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
.345; 2.72; 24.16 mg/177mL; mg/177mL; mg/177mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calamine Plus Pramoxine HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXIDE RED.345 mg/177mL
PRAMOXINE HYDROCHLORIDE2.72 mg/177mL
ZINC OXIDE24.16 mg/177mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K09F3G675, 88AYB867L5, SOI2LOH54Z
Rxcui1544717

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-8588-41Calamine Plus Pramoxine HCl177 mL in 1 CANISTERAEROSOL, SPRAY17710

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G675CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
FERRIC OXIDE REDACTIVE MOIETY1K09F3G675CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
PRAMOXINEACTIVE MOIETY068X84E056CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09LCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
ISOBUTANEINACTIVE INGREDIENTBXR49TP611CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1
SORBITAN TRIOLEATEINACTIVE INGREDIENTQE6F49RPJ1CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-8588CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS NO-TOUCH) AEROSOL, SPRAY [WALGREENS COMPANY]9Current NDC, Legacy NDC, 1 package rows20241211_33219878-f102-46c6-bd63-e83d54fa2785.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSN33219878-f102-46c6-bd63-e83d54fa278510
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD33219878-f102-46c6-bd63-e83d54fa278510
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySY33219878-f102-46c6-bd63-e83d54fa278510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-8588-4100363858841177 mL in 1 CANISTER (0363-8588-41) 177 ml2013-03-120000-00-00NoNoCurrent