Calamine Plus Pramoxine HCl

Product NDC: 81522-959
11-digit product format: 815220959
Labeler code: 81522
Product ID: 81522-959_3cd1933c-6340-50d6-e063-6294a90aca32
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine Plus Spray
Dosage form: AEROSOL, SPRAY
Route: TOPICAL
Labeler: FSA Store Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-08-12
Substance: FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength: 5; 75; 10 mg/g; mg/g; mg/g
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

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: Calamine Plus Pramoxine HCl
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERRIC OXIDE RED	5 mg/g
ZINC OXIDE	75 mg/g
PRAMOXINE HYDROCHLORIDE	10 mg/g

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1544717	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
3cd18f96-34f7-3f2c-e063-6294a90a3b7e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	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
81522-959-01	Calamine Plus Pramoxine HCl	116 g in 1 CAN	AEROSOL, SPRAY	116		1

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 136 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SunBurnt PLUS	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	12128c75-015d-8a72-e063-6394a90ae00a	2024-02-23	Warnings	Exact identifier application number: M017
Kroger Analgesic Analgesic	LIDOCAINE HYDROCHLORIDE	THE KROGER CO	e6c5ead3-87d0-48ed-a4dc-86cf89ebb285	2024-02-22	Warnings	Exact identifier application number: M017
Rugby Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Bryant Ranch Prepack	fcf48536-224e-4a3d-9124-770031823972	2024-02-22	Warnings	Exact identifier application number: M017
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	8bc3956b-b82d-4ed3-8bc3-db0078466bbc	2024-02-22	Warnings	Exact identifier application number: M017
Promescent Delay Wipes	BENZOCAINE	Absorption	f0a5b6be-acc5-473c-9054-b9534e769db1	2024-02-20	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	721658dc-3b1d-43ff-9032-e96851633cf9	2024-02-19	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief Roll on	MENTHOL	Troy Manufacturing, Inc.	978d5c2c-fdc4-4d25-83ec-0b9404ec8018	2024-02-19	Warnings	Exact identifier application number: M017
1168	1168 BURN SPRAY	Dynarex Corporation	1183a4f5-f875-dfb0-e063-6394a90af35f	2024-02-16	Warnings	Exact identifier application number: M017
Pain Relief	BENZOCAINE	Safetec of America, Inc.	de84e598-d047-4fae-b2ed-155a3788bc6f	2024-02-16	Warnings	Exact identifier application number: M017
No Mess Hydrocortisone Applicator	HYDROCORTISONE	Walgreen Co.	cfefb517-9099-41c4-8a95-74414ca4032c	2024-02-16	Warnings	Exact identifier application number: M017
Analgesic Balm	MENTHOL 10%, METHYL SALICYLATE 15%	Geri-Care Pharmaceuticals, Corp	ab9bf09d-bc8c-6d17-e053-2995a90a6c36	2024-02-14	Warnings	Exact identifier application number: M017
Natures Oil 16% Menthol	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	2fbe23b7-23a3-4f0b-bc08-0205256f5d68	2024-02-14	Warnings	Exact identifier application number: M017
Rugby Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Rugby Laboratories	4c11876c-57ec-4429-a8c4-fb95baa4074a	2024-02-13	Warnings	Exact identifier application number: M017
Itch stopping Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	11368823-d4af-a536-e063-6294a90a7a2e	2024-02-12	Warnings	Exact identifier application number: M017
Walgreens Boil Pain Relief	BOIL PAIN RELIEF	Walgreens Company	d11bd769-68d0-4057-bc2a-72719f16011e	2024-02-12	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	Rugby Laboratories	c5915c84-84a2-46f6-9f97-0d9873e9944a	2024-02-12	Warnings	Exact identifier application number: M017
Leader Ice Blue Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	952e56ea-5cbc-4078-bd01-5d3b6864a5ce	2024-02-09	Warnings	Exact identifier application number: M017
Leader Ultra Strength Muscle Rub Topical Analgesic	CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE	Cardinal Health, 110 dba LEADER	9d99a900-60e0-454c-98e0-2c63eb910cf1	2024-02-09	Warnings	Exact identifier application number: M017
Pain Relieving	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	28821ffa-a138-47b5-8857-beadf7a20d43	2024-02-08	Warnings	Exact identifier application number: M017
Menthol Camphor Cough Suppressant Topical Analgesic Rub	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	fd0ea70a-ef12-48b1-8d9d-cc5f6417f854	2024-02-08	Warnings	Exact identifier application number: M017

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1544717	calamine 8 % / pramoxine HCl 1 % Topical Spray	PSN	3cd18f96-34f7-3f2c-e063-6294a90a3b7e	1
1544717	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray	SCD	3cd18f96-34f7-3f2c-e063-6294a90a3b7e	1
1544717	calamine 8 % / pramoxine hydrochloride 1 % Topical Spray	SY	3cd18f96-34f7-3f2c-e063-6294a90a3b7e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81522-959-01	81522095901	116 g in 1 CAN (81522-959-01)	116 g	2025-08-12	No	No	Current