FDA.reportPublic FDA data

Calamine Plus

Product NDC
49035-030
Requested package NDC
49035-030-01
11-digit product format
490350030
Labeler code
49035
Product ID
49035-030_c6f18218-8fff-bd9f-e053-2a95a90ad1c7
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Wal-Mart Stores, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-03-03
Marketing end
0000-00-00
Substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
0 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49035-03049035-030-01DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

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
49035-030-01Calamine Plus177 mL in 1 CANISTERAEROSOL, SPRAY17711

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G675CALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5CALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2
FERRIC OXIDE REDACTIVE MOIETY1K09F3G675CALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2
PRAMOXINEACTIVE MOIETY068X84E056CALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETCALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2
ISOBUTANEINACTIVE INGREDIENTBXR49TP611CALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVCALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2
SORBITAN TRIOLEATEINACTIVE INGREDIENTQE6F49RPJ1CALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-030CALAMINE PLUS (FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) AEROSOL, SPRAY [WAL-MART STORES, INC.]10Legacy NDC, 1 package rows20241109_eba4b13f-bc23-45d5-b01e-8ca10cdbb2cc.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calamine PlusFERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDEWal-Mart Stores, Inc.eba4b13f-bc23-45d5-b01e-8ca10cdbb2cc2025-06-21WarningsExact identifier
ndc (package): 49035-030-01
ndc (product): 49035-030
ndc11 (package): 49035003001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSNeba4b13f-bc23-45d5-b01e-8ca10cdbb2cc11
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCDeba4b13f-bc23-45d5-b01e-8ca10cdbb2cc11
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySYeba4b13f-bc23-45d5-b01e-8ca10cdbb2cc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-030-0149035003001177 mL in 1 CANISTER (49035-030-01) 177 ml2013-03-030000-00-00NoNoCurrent