FDA.reportPublic FDA data

Caladryl Clear

Product NDC
0187-5466
11-digit product format
001875466
Labeler code
0187
Product ID
0187-5466_24adc674-5fba-e779-e063-6294a90ad250
Type
HUMAN OTC DRUG
Nonproprietary name
PRAMOXINE HYDROCHLORIDE and ZINC ACETATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-16
Substance
PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength
10; 1 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0187-5466-06IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0187-5466-06IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0187-5466-06EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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 Clear
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC ACETATE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
FM5526K07AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234546Internal RxNorm lookup
1234552Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fca6f08b-7fa0-4ae6-bce3-61f3bcae4332Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-5466-062021-01-12C16284748780-19d75b9d0-3e98-f424-e053-dadaa90a57ceCaladryl Clear
0187-5466-062020-01-31C16284748780-19d75b9d0-3e98-f424-e053-dadaa90a57ceCaladryl Clear

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-5466-06Caladryl Clear177 mL in 1 BOTTLE, PLASTICLOTION1775

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-5466-06ML - Milliliter0187-5466ef571b14-76a6-4ac3-b59d-ff5926d03bf312016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07ACALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
PRAMOXINEACTIVE MOIETY068X84E056CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
ZINC CATIONACTIVE MOIETY13S1S8SF37CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Camphor (Synthetic)INACTIVE INGREDIENT5TJD82A1ETCALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPCALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Diazolidinyl UreaINACTIVE INGREDIENTH5RIZ3MPW4CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOCALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TCALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Polysorbate 40INACTIVE INGREDIENTSTI11B5A2XCALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHCALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRCALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RCALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-5466CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [BAUSCH HEALTH US, LLC]5Current NDC, Legacy NDC, 1 package rows20241019_fca6f08b-7fa0-4ae6-bce3-61f3bcae4332.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
1234552Caladryl Clear 1 % / 0.1 % Topical LotionPSNfca6f08b-7fa0-4ae6-bce3-61f3bcae43325
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSNfca6f08b-7fa0-4ae6-bce3-61f3bcae43325
1234552pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion [Caladryl Clear]SBDfca6f08b-7fa0-4ae6-bce3-61f3bcae43325
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCDfca6f08b-7fa0-4ae6-bce3-61f3bcae43325
1234552Caladryl Clear (pramoxine hydrochloride 1 % / zinc acetate 0.1 % ) Topical LotionSYfca6f08b-7fa0-4ae6-bce3-61f3bcae43325
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSYfca6f08b-7fa0-4ae6-bce3-61f3bcae43325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-5466-0600187546606177 mL in 1 BOTTLE, PLASTIC (0187-5466-06) 177 ml2013-08-160000-00-00NoNoCurrent