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
Ingredient	Strength
FERRIC OXIDE RED	1.36 mg/mL
ZINC OXIDE	10 mg/mL
PRAMOXINE HYDROCHLORIDE	78.65 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1K09F3G675	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1234532	Internal RxNorm lookup
1234533	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
67d4fd42-9fed-4238-9f5a-c9403abbcf20	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0187-5465-06	Caladryl	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-5465-06	ML - Milliliter	0187-5465	d7d2d28a-6ac7-4ac3-9b48-8cb69f309c73	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ferric Oxide Red	ACTIVE INGREDIENT	1K09F3G675	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Pramoxine Hydrochloride	ACTIVE INGREDIENT	88AYB867L5	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Ferric Oxide Red	ACTIVE MOIETY	1K09F3G675	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Pramoxine	ACTIVE MOIETY	068X84E056	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Camphor (Synthetic)	INACTIVE INGREDIENT	5TJD82A1ET	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Diazolidinyl Urea	INACTIVE INGREDIENT	H5RIZ3MPW4	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	CALADRYL (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
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-5465	CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [BAUSCH HEALTH US, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20241019_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 1 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EarBalance Ear Pain Drops	LIDOCAINE HYDROCHLORIDE OTIC SOLUTION	Marie's Original Formulas LLC	54dc3642-0b7a-07d8-e063-6294a90ad556	2026-07-22	Warnings	Exact identifier application number: M014
EarBalance Ear Pain Drops	LIDOCAINE HYDROCHLORIDE OTIC SOLUTION	Marie's Original Formulas LLC	55057e1b-b11e-51b9-e063-6394a90a9fca	2026-07-22	Warnings	Exact identifier application number: M014
Macks Dry n Clear	EAR DRYING AID	McKeon Products Inc	1ea1da54-2412-c25c-e063-6294a90aa264	2026-06-26	Warnings	Exact identifier application number: M014
Equate Swimmers Instant Ear Dry	EQUATE SWIMMERS INSTANT EAR DRY	Walmart Stores, Inc	76b58a7a-48cf-866c-e053-2a91aa0a7e63	2026-06-26	Warnings	Exact identifier application number: M014
Quality Choice Earwax Removal Drops Earwax Removal Aid	CARBAMIDE PEROXIDE	Chain Drug Marketing Association, Inc.	c68b40d9-c1d4-4425-8063-50c00299e718	2026-06-10	Warnings	Exact identifier application number: M014
Quality Choice Earwax Removal Kit Earwax Removal Aid and Bulb	CARBAMIDE PEROXIDE	Chain Drug Marketing Association, Inc.	b2a641da-e070-4223-b836-5ca9ffb89f3f	2026-06-10	Warnings	Exact identifier application number: M014
Freskaro Ear Drops for Swimmers	FRESKARO EAR DROPS FOR SWIMMERS	Pharma Nobis, LLC	4f724d85-cd38-41da-e063-6394a90a9fd7	2026-06-03	Warnings	Exact identifier application number: M014
Audiologists Choice Earwax Removal System	CARBAMIDE PEROXIDE	Oaktree Products Inc.	c9ad507b-341c-474f-aaa2-3c3a97a30dd8	2026-05-29	Warnings	Exact identifier application number: M014
CVS Health Earwax Removal Kit	CARBAMIDE PEROXIDE	CVS Pharmacy, Inc.	f842534c-46dd-42c7-8386-9a03ce16da86	2026-05-29	Warnings	Exact identifier application number: M014
Lucid Hearing Earwax Removal Kit and Bulb	CARBAMIDE PEROXIDE	Hearing Lab Technology LLC	5e09f566-397f-44d6-8ba2-90987765c737	2026-05-29	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal Drops	CARBAMIDE PEROXIDE	Amerisource Bergen	89eac1b0-c700-45b5-8478-da53ace72e16	2026-05-29	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal	CARBAMIDE PEROXIDE	Amerisource Bergen	d503b10f-85cd-4bb8-9dec-82d651d525fa	2026-05-29	Warnings	Exact identifier application number: M014
Meijer Earwax Removal Kit	CARBAMIDE PEROXIDE	Meijer Distribution Inc.	a5f7bd55-55c3-4b0e-a16c-33bbea40536a	2026-05-29	Warnings	Exact identifier application number: M014
Quality Choice Earwax Removal Drops	CARBAMIDE PEROXIDE	Chain Drug Marketing Association, Inc.	d8fd8102-114f-415d-9083-f98a63f9d1b3	2026-05-29	Warnings	Exact identifier application number: M014
Menthol Pain Relieving Gel	PAIN RELIEVING GEL	NeilMed Pharmaceuticals Inc	513a206c-bbf6-3e51-e063-6294a90adf7a	2026-05-07	Warnings	Exact identifier application number: M014
ear drops	CARBAMIDE PEROXIDE 6.5%	Bionpharma Inc.	e8bcf92c-ad32-49d5-e053-2995a90ae0c6	2026-04-27	Warnings	Exact identifier application number: M014
Freskaro Earwax Removal Aid	CARBAMIDE PEROXIDE 6.50% KIT	Pharma Nobis, LLC	4f5967ee-bc05-341c-e063-6394a90a35c6	2026-04-15	Warnings	Exact identifier application number: M014
GoodSense Ear Wax Removal Kit	CARBAMIDE PEROXIDE	Preferred Pharmaceuticals Inc.	9a4198d2-cbea-466a-a252-d5c63d9ea0c1	2026-04-09	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal Drops	CARBAMIDE PEROXIDE	Preferred Pharmaceuticals Inc.	52f733a7-1301-4078-9267-5ce95b006ccc	2026-04-09	Warnings	Exact identifier application number: M014
Walgreens Swimmers Ear	ISOPROPYL ALCOHOL	Walgreens Co	3fb65a5c-c47f-ef2b-e063-6394a90af21a	2026-04-01	Warnings	Exact identifier application number: M014

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K09F3G675	FERRIC OXIDE RED	1309-37-1	FERRIC OXIDE RED
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1234533	Caladryl 8 % / 1 % Topical Lotion	PSN	67d4fd42-9fed-4238-9f5a-c9403abbcf20	6
1234532	calamine 8 % / pramoxine HCl 1 % Topical Lotion	PSN	67d4fd42-9fed-4238-9f5a-c9403abbcf20	6
1234533	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Caladryl]	SBD	67d4fd42-9fed-4238-9f5a-c9403abbcf20	6
1234532	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	67d4fd42-9fed-4238-9f5a-c9403abbcf20	6
1234533	Caladryl (calamine 8 % / pramoxine hydrochloride 1 % ) Topical Lotion	SY	67d4fd42-9fed-4238-9f5a-c9403abbcf20	6
1234532	calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion	SY	67d4fd42-9fed-4238-9f5a-c9403abbcf20	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-5465-06	00187546506	177 mL in 1 BOTTLE, PLASTIC (0187-5465-06)	177 ml	2013-08-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Caladryl Pink	Bausch Health US, LLC \| Trillium Health Care Products Inc.	2024-10-17	HUMAN OTC DRUG LABEL	6