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
ZINC OXIDE2.72 mg/177mL
PRAMOXINE HYDROCHLORIDE24.16 mg/177mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1K09F3G675Internal UNII lookup
SOI2LOH54ZInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1544717Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33219878-f102-46c6-bd63-e83d54fa2785Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 154 · 3,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jakwork Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5911d9b0-1acb-3546-e063-6294a90adb3a2026-08-15WarningsExact identifier
application number: M017
RVDU WARMING PAIN RELIEFCAPSAICINQIRUI NETWORK (SHENZHEN) CO., LTD.58eb2a86-bf25-d4b5-e063-6394a90af8c42026-08-13WarningsExact identifier
application number: M017
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
application number: M017
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
application number: M017
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact identifier
application number: M017
RELIBONEOintmentTOPICAL ANALGESICOINTMENTGuangdong Jiaoyu Biotechnology Co., Ltd58ddaaf6-18ec-8c5b-e063-6294a90a28282026-08-12WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58de3a29-2bec-6e44-e063-6394a90a9c1a2026-08-12WarningsExact identifier
application number: M017
Muscle Rub CreamMUSCLE RUBALLIED TRADE LINK LLC11d33e60-8c64-4316-a29a-d17e3e6e4a282026-08-11WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-11WarningsExact identifier
application number: M017
Arctic Ice Pain Relieving GelMENTHOLONEST LIMITEDc63ef7a5-d649-4fba-9361-d37f1150e21d2026-08-11WarningsExact identifier
application number: M017
Gee GasonMALE GENITAL DESENSITIZERMon Gars Boutique Inc58c75e5c-b801-017f-e063-6394a90a1c752026-08-11WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58c84330-15bf-c397-e063-6394a90aba052026-08-11WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsExact identifier
application number: M017
Medicated BODYMENTHOLCVS Pharmacy, Inc.a0f61498-69c8-4ce0-bbd7-3a807f192d362026-08-11WarningsExact identifier
application number: M017
Muscle MoveMENTHOLSaje Natural Wellness Inc.526d3305-4cf8-2fc5-e063-6394a90ad53b2026-08-10WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOLCVS Pharmacy4aa629f5-8b8f-cc67-e063-6394a90a019f2026-08-07WarningsExact identifier
application number: M017
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsExact identifier
application number: M017
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy46921bea-fcbe-94d6-e063-6394a90a726b2026-08-07WarningsExact identifier
application number: M017

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