FDA.reportPublic FDA data

Calamine Plus

Product NDC
49035-030
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49035-030DDiscontinued by firm2026-11-03
excluded packagepackage49035-03049035-030-01DDiscontinued by firm2026-11-03

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

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