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; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength
1.36; 78.65; 10 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

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
ZINC OXIDE78.65 mg/mL
PRAMOXINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1K09F3G675Internal UNII lookup
SOI2LOH54ZInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234532Internal RxNorm lookup
1234533Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
67d4fd42-9fed-4238-9f5a-c9403abbcf20Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-5465-06ML - Milliliter0187-5465d7d2d28a-6ac7-4ac3-9b48-8cb69f309c7312015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ferric Oxide RedACTIVE INGREDIENT1K09F3G675CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L5CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZCALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Ferric Oxide RedACTIVE MOIETY1K09F3G675CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
PramoxineACTIVE MOIETY068X84E056CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZCALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Camphor (Synthetic)INACTIVE INGREDIENT5TJD82A1ETCALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Diazolidinyl UreaINACTIVE INGREDIENTH5RIZ3MPW4CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOCALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TCALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHCALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RCALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEECALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1

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

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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact identifier
application number: M014

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