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 date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0187-5466-06	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0187-5466-06	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0187-5466-06	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`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
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/mL
ZINC ACETATE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88AYB867L5	Internal UNII lookup
FM5526K07A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
fca6f08b-7fa0-4ae6-bce3-61f3bcae4332	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0187-5466-06	2021-01-12	C162847	48780-1	9d75b9d0-3e98-f424-e053-dadaa90a57ce	Caladryl Clear
0187-5466-06	2020-01-31	C162847	48780-1	9d75b9d0-3e98-f424-e053-dadaa90a57ce	Caladryl Clear

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0187-5466-06	Caladryl Clear	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-5466-06	ML - Milliliter	0187-5466	ef571b14-76a6-4ac3-b59d-ff5926d03bf3	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
ZINC ACETATE	ACTIVE INGREDIENT	FM5526K07A	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Camphor (Synthetic)	INACTIVE INGREDIENT	5TJD82A1ET	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Diazolidinyl Urea	INACTIVE INGREDIENT	H5RIZ3MPW4	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Polysorbate 40	INACTIVE INGREDIENT	STI11B5A2X	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-5466	CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [BAUSCH HEALTH US, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20241019_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 3 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HANCHOBIT Lemon Turmeric Kojic Acid Brightening	GLYCERIN	HANCHOYEANBIOTEC Co.,Ltd.	2ded8f31-d72a-d123-e063-6294a90a2856	2025-11-27	Warnings	Exact identifier application number: M014
XIMONTH Wart Remover	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	337d4d37-c2d6-44d3-e063-6294a90a77ce	2025-11-26	Warnings	Exact identifier application number: M014
Swimmers Ear	CLEARCANAL	Neilmed Pharmaceuticals Inc.	43778b02-e90b-36b7-e063-6394a90ab62b	2025-11-13	Warnings	Exact identifier application number: M014
Hand Sanitizer	ALCOHOL	Charlotte Products Ltd.	1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa	2025-10-28	Warnings	Exact identifier application number: M014
Carbamide peroxide 6.5%	EARWAX REMOVAL KIT	Allegiant Health	54515e9d-2225-4875-a1cf-a24a823300dd	2025-10-28	Warnings	Exact identifier application number: M014
OFTAL-MYCIN LUBRICANT OPHTHALMIC	LIGHT MINERAL, WHITE PETROLATUM	GRANDALL DISTRIBUTING, LLC	298db04a-21a9-e46e-e063-6294a90acee2	2025-10-27	Warnings	Exact identifier application number: M014
Debrox Swimmers Ear	ISOPROPYL ALCOHOL	Medtech Products Inc.	b5d57c7b-8315-4260-967e-38fdd54e2a9c	2025-10-23	Warnings	Exact identifier application number: M014
Family Care Earwax Removal	CARBAMIDE PEROXIDE	United Exchange Corp.	958741f5-47c1-339c-e053-2a95a90a3f5f	2025-10-22	Warnings	Exact identifier application number: M014
GoodSense Ear Wax Removal Kit	CARBAMIDE PEROXIDE	Geiss, Destin & Dunn, Inc	31ea324f-a9a1-7865-e063-6294a90a92e8	2025-09-19	Warnings	Exact identifier application number: M014
blue goo NERVE EASE Pain RELIEF Topical Analgesic	LIDOCAINE HCL 4%, MENTHOL 1%	Garcoa, Inc.	619d5c87-636c-407d-909e-c38512dcd553	2025-09-10	Warnings	Exact identifier application number: M014
DEBROX	CARBAMIDE PEROXIDE	A-S Medication Solutions	8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1	2025-09-03	Warnings	Exact identifier application number: M014
Auralyt	CARBAMIDE PEROXIDE	Menper Distributors, Inc	95920b87-941f-48cb-850c-40d2735596d4	2025-07-22	Warnings	Exact identifier application number: M014
hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	a0fde5c9-afb2-76a9-e053-2995a90af3e8	2025-07-21	Warnings	Exact identifier application number: M014
Healthy Ears	CARBIDE PEROXIDE	Vitamex USA, Corp	25953441-cd8e-5038-e063-6294a90ae401	2025-06-23	Warnings	Exact identifier application number: M014
WaxRx Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	DOCTOR EASY MEDICAL PRODUCTS, LLC	7e08cd86-7ae4-7d12-e053-2991aa0a4cba	2025-05-01	Warnings	Exact identifier application number: M014
Meijer Earwax Removal Drops	CARBAMIDE PEROXIDE	Meijer Distribution Inc	900108c6-0324-644a-e053-2a95a90a3b2b	2025-02-28	Warnings	Exact identifier application number: M014
Tech Care Earwax Removal Kit	CARBAMIDE PEROXIDE	Warner Tech-care Products, LLC	5851c1f6-c15b-447c-b495-3707e7a12bdb	2025-02-28	Warnings	Exact identifier application number: M014
Tech Care Earwax Removal Drops	CARBAMIDE PEROXIDE	Warner Tech-care Products, LLC	1c97783b-dcdf-4f95-8516-0d7f197cbc27	2025-02-28	Warnings	Exact identifier application number: M014
TopCare Earwax Removal Kit	CARBAMIDE PEROXIDE	TOPCO ASSOCIATES LLC	890cc9b6-41a5-480a-bc94-45c8d4fdeef3	2025-02-28	Warnings	Exact identifier application number: M014
Audiologists Choice Earwax Removal Aid Drops	CARBAMIDE PEROXIDE	Oaktree Products Inc	2922dde2-d082-437b-8f51-4a91ced20a58	2025-02-28	Warnings	Exact identifier application number: M014

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE
FM5526K07A	ZINC ACETATE	5970-45-6	ZINC ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1234552	Caladryl Clear 1 % / 0.1 % Topical Lotion	PSN	fca6f08b-7fa0-4ae6-bce3-61f3bcae4332	5
1234546	pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion	PSN	fca6f08b-7fa0-4ae6-bce3-61f3bcae4332	5
1234552	pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion [Caladryl Clear]	SBD	fca6f08b-7fa0-4ae6-bce3-61f3bcae4332	5
1234546	pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion	SCD	fca6f08b-7fa0-4ae6-bce3-61f3bcae4332	5
1234552	Caladryl Clear (pramoxine hydrochloride 1 % / zinc acetate 0.1 % ) Topical Lotion	SY	fca6f08b-7fa0-4ae6-bce3-61f3bcae4332	5
1234546	pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion	SY	fca6f08b-7fa0-4ae6-bce3-61f3bcae4332	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-5466-06	00187546606	177 mL in 1 BOTTLE, PLASTIC (0187-5466-06)	177 ml	2013-08-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Caladryl Clear	Bausch Health US, LLC \| Trillium Health Care Products Inc.	2024-10-17	HUMAN OTC DRUG LABEL	5