Calamine Plus Pramoxine HCl

Product NDC
56104-251
11-digit product format
561040251
Labeler code
56104
Product ID
56104-251_4229a38a-85a1-4153-e063-6294a90a7971
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine Plus Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Premier Brands of America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-20
Substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
.345; 2.72; 24.16 mg/116g; mg/116g; mg/116g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calamine Plus Pramoxine HCl
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K09F3G675, 88AYB867L5, SOI2LOH54Z

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
56104-251-00Calamine Plus Pramoxine HCl116 g in 1 CANISTERAEROSOL, SPRAY1166

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-251CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA, INC.]5Current NDC, Legacy NDC, 1 package rows20250116_d3452573-f91f-f157-e053-2a95a90a1ad8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-251-0056104025100116 g in 1 CANISTER (56104-251-00) 116 g2021-12-200000-00-00NoNoCurrent