FDA.reportPublic FDA data

Calamine Plus Pramoxine HCl

Product NDC
59779-174
11-digit product format
597790174
Labeler code
59779
Product ID
59779-174_518c2130-11d8-06d3-e063-6394a90ad196
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine Plus Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-01
Substance
FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength
.345; 24.16; 2.72 mg/116g; mg/116g; mg/116g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Calamine Plus Pramoxine HCl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXIDE RED.345 mg/116g
ZINC OXIDE24.16 mg/116g
PRAMOXINE HYDROCHLORIDE2.72 mg/116g

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
db6f518d-3a0e-43f8-8d19-7382d9b7ff1cAvailable on FDA.report

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
59779-174-41Calamine Plus Pramoxine HCl116 g in 1 CANISTERAEROSOL, SPRAY11615
59779-174-65Calamine Plus Pramoxine HCl184 g in 1 CANISTERAEROSOL, SPRAY18415

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G675CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
FERRIC OXIDE REDACTIVE MOIETY1K09F3G675CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
PRAMOXINEACTIVE MOIETY068X84E056CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09LCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
ISOBUTANEINACTIVE INGREDIENTBXR49TP611CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVCALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
SORBITAN TRIOLEATEINACTIVE INGREDIENTQE6F49RPJ1CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-174CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]12Current NDC, Legacy NDC, 2 package rows20241109_db6f518d-3a0e-43f8-8d19-7382d9b7ff1c.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 5 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsExact identifier
application number: M017
Muscle Rub CreamMUSCLE RUBALLIED TRADE LINK LLC11d33e60-8c64-4316-a29a-d17e3e6e4a282026-08-11WarningsExact 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
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy0e988da1-1904-431d-a152-bdb2aacc8e162026-08-11WarningsExact 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
Relieve and Relax Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLMAC Innovations, LLCc0528c36-d322-8110-e053-2995a90add6c2026-08-08WarningsExact 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
CVS Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Pharmacy524605f9-8b04-b600-e063-6394a90a4a022026-08-07WarningsExact identifier
application number: M017
LidonexLIDOCAINE HCL, MENTHOLAldama Pharmaceuticals, Inc365cf19c-70e0-c4e9-e063-6294a90ac4282026-08-07WarningsExact identifier
application number: M017
Blaster Pain Relief StickMENTHOL, METHYL SALICYLATE, CAMPHORKalahari Rose, LLC587d660a-5f80-de5a-e063-6394a90aa2872026-08-07WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECardinal Health, 110 dba Leader3ed7b8a1-012f-459d-878c-813b93d4673c2026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSNdb6f518d-3a0e-43f8-8d19-7382d9b7ff1c15
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCDdb6f518d-3a0e-43f8-8d19-7382d9b7ff1c15
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySYdb6f518d-3a0e-43f8-8d19-7382d9b7ff1c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-174-4159779017441116 g in 1 CANISTER (59779-174-41) 116 g2014-01-010000-00-00NoNoCurrent
59779-174-6559779017465184 g in 1 CANISTER (59779-174-65) 184 g2019-10-280000-00-00NoNoCurrent