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 59 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thera Plus Maximum Strength HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc7d4e21d1-2914-4690-9084-a52abeab09582025-12-02WarningsExact identifier
application number: M017
Rugby Capsaicin CreamCAPSAICINRugby Laboratories9eca34f1-e91a-3ac1-e053-2a95a90a9bd92025-12-02WarningsExact identifier
application number: M017
Leader Capsaicin Pain Relief CreamCAPSAICINCardinal Health 110 dba LEADERa5620709-0fed-4979-e053-2a95a90ac6542025-12-02WarningsExact identifier
application number: M017
Hydrocortisone Acetate Antipruritic (Anti-Itch)HYDROCORTISONE ACETATESun Pharmaceutical Industries, Inc.9f0b09e7-6cfd-4fd6-8631-67799edf4e082025-12-02WarningsExact identifier
application number: M017
POMG NIGHT TIME PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDEPOMG LLC28d7dfb0-a94c-90de-e063-6294a90a036a2025-12-02WarningsExact identifier
application number: M017
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
application number: M017
SUNSET COOLING PAIN RELIEF ROLL-ONMENTHOLSUNSET NOVELTIES, INC45037bc1-aa03-11ae-e063-6294a90a6c962025-12-02WarningsExact identifier
application number: M017
SUNSET HEATING PAIN RELIEF ROLL-ONCAMPHORSUNSET NOVELTIES, INC45048936-f3c9-25f7-e063-6394a90ac4a92025-12-02WarningsExact identifier
application number: M017
CAREALL Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAMNew World Imports, Inc3a01f57a-ebc6-4724-b625-1d1ea4b85e732025-12-01WarningsExact identifier
application number: M017
CareALL Arthritis and MuscleCAPSAICINNew World Imports, Inc4867eac4-00ea-434e-b289-1c1ef0342c232025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Ince2df8130-e7c8-4fde-a6d6-c713789912132025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incd04e473d-8bbc-475c-a0b1-ca5eed67fbc72025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Inccba7c084-379f-4a16-aeba-b11ca6e20d8a2025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Incd066002d-8ceb-4d16-9744-d5ca25d2ad5a2025-12-01WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc013beea4-b2c2-4e84-b4cb-3125ac48e8c02025-12-01WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINA2A Integrated Pharmaceuticals, LLC147f3594-7362-7a78-e063-6294a90a3e422025-11-30WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey6b9258e4-c7c4-765e-e053-2991aa0a9f4e2025-11-29WarningsExact identifier
application number: M017
Walgreen Pain Relieving Fragrance FreeLIDOCAINE HYDROCHLORIDEWALGREENS CO.62c50ded-3fc9-4f65-9bfb-1144ed2e36b42025-11-26WarningsExact identifier
application number: M017
Itch ReliefITCH RELIEF GELNeilmed Pharmaceuticals Inc.44811828-c32e-17fc-e063-6294a90add482025-11-26WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact 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