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 13 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr SabharwalsMETHYL SALICYLATE 10% GEL PATCHDr. Sabharwal's Wound Care4a7790bb-25cb-72b8-e063-6294a90a6b9c2026-06-29WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
application number: M017
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIUnishieldf86f7446-b741-9f40-e053-6394a90a44222026-06-29WarningsExact identifier
application number: M017
MQ Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5560cdab-cee8-f6ec-e063-6294a90ad0242026-06-29WarningsExact identifier
application number: M017
GNP Lidocaine Maximum StrengthLIDOCAINE HCLAMERISOURCE BERGEN9f559c20-c9ac-e480-e053-2a95a90a8fce2026-06-29WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED5553385d-c1e6-1242-e063-6394a90aa5a72026-06-28WarningsExact identifier
application number: M017
MOROVANLIDOCAINEHONG KONG UNORDERED TRADING CO., LIMITED550c8d2d-e0d7-1531-e063-6394a90a374d2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas, LLC5517ee5f-1c51-cfd6-e063-6294a90af56f2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas LLC55188ede-68cd-fcc6-e063-6394a90a5c582026-06-25WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%NuCare Pharmaceuticals, Inc.54f07a23-213f-ca46-e063-6394a90a00342026-06-24WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONMENTHOL,PRAMOXINE HYDROCHLORIDERida LLCb62d09e4-7ced-49a9-8c83-3a8ef580f25a2026-06-23WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONPRAMOXINE HYDROCHLORIDERida LLC5b2cb1bd-2f1e-4670-b40e-6c058bfd12a22026-06-23WarningsExact identifier
application number: M017
Pain Relieving cleansing sparyBENZALKONIUM CHLORIDE AND LIDOCAINE HCITrifecta Pharmaceuticals USA, LLC.48edbb8d-0c35-91d8-e063-6394a90a71b82026-06-19WarningsExact identifier
application number: M017
Pain ReliefMENTHOLTrifecta Pharmaceuticals USA, LLC.493ab515-5cda-7b5a-e063-6294a90a295b2026-06-19WarningsExact identifier
application number: M017
Tiger Balm Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.011fc383-10bc-44cf-a67c-4be45fef33e02026-06-19WarningsExact identifier
application number: M017
CVS Health Scalp ReliefSALICYLIC ACIDCVS Health8de46015-817c-4cd9-95f8-293424f2a5c42026-06-19WarningsExact identifier
application number: M017
Careland Kinesiology Dual Action Pain Relieving TapeLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.67e0b3c5-e88e-4c48-a1e8-39f502ac249d2026-06-18WarningsExact identifier
application number: M017
ZensaLIDOCAINEAlera Skin Care Products Inc.549348ec-2eb2-3781-e063-6294a90a2f4a2026-06-18WarningsExact identifier
application number: M017
SprayPain AwayCAPSAICINProximity Capital Partners LLC dba Asutrac603e999-2316-496a-e053-2995a90ab4ed2026-06-17WarningsExact identifier
application number: M017
SprayPain Away LavenderCAPSAICINProximity Capital Partners LLC dba Asutra547e2167-ade0-ac7e-e063-6294a90a18ea2026-06-17WarningsExact 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