Calamine Plus Pramoxine HCl

Product NDC
56104-100
11-digit product format
561040100
Labeler code
56104
Product ID
56104-100_42b813fe-1a86-a199-e063-6394a90a1eff
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine Plus No Touch Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-28
Substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
5; 10; 75 mg/g; mg/g; mg/g
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 RED5 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g
ZINC OXIDE75 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K09F3G675, 88AYB867L5, SOI2LOH54Z
Rxcui1544717

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-100-10Calamine Plus Pramoxine HCl116 g in 1 CANAEROSOL, SPRAY1163

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSN36481d67-2346-470b-e063-6294a90aae993
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD36481d67-2346-470b-e063-6294a90aae993
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySY36481d67-2346-470b-e063-6294a90aae993

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
56104-100-1056104010010116 g in 1 CAN (56104-100-10) 116 g2025-05-28NoNoHistorical