FDA.reportPublic FDA data

Caladryl

Product NDC
0187-5465
11-digit product format
001875465
Labeler code
0187
Product ID
0187-5465_24add3ce-a1f0-0b6a-e063-6394a90a77c2
Type
HUMAN OTC DRUG
Nonproprietary name
Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-16
Substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
1.36; 10; 78.65 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Caladryl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXIDE RED1.36 mg/mL
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC OXIDE78.65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K09F3G675, 88AYB867L5, SOI2LOH54Z
Rxcui1234532, 1234533

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
0187-5465-06Caladryl177 mL in 1 BOTTLE, PLASTICLOTION1776

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-5465CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [BAUSCH HEALTH US, LLC]6Current NDC, Legacy NDC, 1 package rows20241019_67d4fd42-9fed-4238-9f5a-c9403abbcf20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234533Caladryl 8 % / 1 % Topical LotionPSN67d4fd42-9fed-4238-9f5a-c9403abbcf206
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN67d4fd42-9fed-4238-9f5a-c9403abbcf206
1234533calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Caladryl]SBD67d4fd42-9fed-4238-9f5a-c9403abbcf206
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD67d4fd42-9fed-4238-9f5a-c9403abbcf206
1234533Caladryl (calamine 8 % / pramoxine hydrochloride 1 % ) Topical LotionSY67d4fd42-9fed-4238-9f5a-c9403abbcf206
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY67d4fd42-9fed-4238-9f5a-c9403abbcf206

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-5465-0600187546506177 mL in 1 BOTTLE, PLASTIC (0187-5465-06) 177 ml2013-08-160000-00-00NoNoCurrent