Calamine Plus Pramoxine HCl

Product NDC: 59779-174
11-digit product format: 597790174
Labeler code: 59779
Product ID: 59779-174_518c2130-11d8-06d3-e063-6394a90ad196
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine Plus Spray
Dosage form: AEROSOL, SPRAY
Route: TOPICAL
Labeler: CVS Pharmacy
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-01
Substance: FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength: .345; 24.16; 2.72 mg/116g; mg/116g; mg/116g
NDC exclude flag: No
Listing certified through: 2027-12-31
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERRIC OXIDE RED	.345 mg/116g
ZINC OXIDE	24.16 mg/116g
PRAMOXINE HYDROCHLORIDE	2.72 mg/116g

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
db6f518d-3a0e-43f8-8d19-7382d9b7ff1c	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
59779-174-41	Calamine Plus Pramoxine HCl	116 g in 1 CANISTER	AEROSOL, SPRAY	116		15
59779-174-65	Calamine Plus Pramoxine HCl	184 g in 1 CANISTER	AEROSOL, SPRAY	184		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FERRIC OXIDE RED	ACTIVE INGREDIENT	1K09F3G675	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
FERRIC OXIDE RED	ACTIVE MOIETY	1K09F3G675	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
DISTEARDIMONIUM HECTORITE	INACTIVE INGREDIENT	X687XDK09L	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
ISOBUTANE	INACTIVE INGREDIENT	BXR49TP611	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
OLEYL ALCOHOL	INACTIVE INGREDIENT	172F2WN8DV	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1
SORBITAN TRIOLEATE	INACTIVE INGREDIENT	QE6F49RPJ1	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-174	CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [CVS PHARMACY]	12	Current NDC, Legacy NDC, 2 package rows	20241109_db6f518d-3a0e-43f8-8d19-7382d9b7ff1c.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 143 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	b505769e-9c46-3cf3-e053-2a95a90a4df9	2023-11-17	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	d6523993-d781-cdbc-e053-2a95a90af191	2023-11-17	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	4d91baf3-9655-4786-93b8-aa0d93fe0bf9	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE LEG CRAMP	MENTHOL	KOBAYASHI Healthcare International, Inc.	7ef03298-6623-4cf4-b21f-74b2ffc11c6e	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	436e8578-b609-4b45-8f84-0d111140fda6	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL	KOBAYASHI Healthcare International, Inc.	08dcfa78-7332-4f19-90d7-fdd7d446848a	2023-11-16	Warnings	Exact identifier application number: M017
Totally Fun After Sun	LIDOCAINE HCL	MJ Products Association, LLC	965a2a29-914c-4ad0-b25f-5df3c30da393	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f	2023-11-15	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	b44beac3-1d20-434f-9a79-4fab1ac68791	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	79ad55eb-b59d-4bb8-88e3-3b51e10a7f28	2023-11-15	Warnings	Exact identifier application number: M017
PURE EASE Joint Muscle lnstant Pain Relief	CAPSAICIN, MENTHOL	SERENU, INC.	42bf129c-5c84-4331-b6d0-78e3be71a985	2023-11-13	Warnings	Exact identifier application number: M017
PURE EASE Neur Cream Instant Deep Pain Relief	CAPSAICIN, MENTHOL	SERENU, INC.	e46a4636-6405-440a-a05a-862c354bab54	2023-11-13	Warnings	Exact identifier application number: M017
Cryomax Cooling	MENTHOL	LIFE WEAR TECHNOLOGIES	0a0ae5ba-9fac-45f6-e063-6294a90ad555	2023-11-13	Warnings	Exact identifier application number: M017
LBri Super Aloe Stop The Pain	METHYL SALICYLATE, MENTHOL, CAPSAICIN	L'Bris, Pure 'N Natural	8fb2010c-c34b-4552-858d-a0188ad313ad	2023-11-11	Warnings	Exact identifier application number: M017
TOTAL RELIEF	HYDROCORTISONE	DR. MARDER SKINCARE, LLC	2c05459c-5a2c-45ab-b534-87f966b41681	2023-11-11	Warnings	Exact identifier application number: M017
Human Science Muscle Pain Relief	METHYL SALICYLATE, MENTHOL	Human Science, LLC	4bccc017-264b-11ce-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE HYDROCHLORIDE, MENTHOL	Village Pharma, LLC	55108ffd-d6a8-41de-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier application number: M017
Debbies Down and Dirty Deep Tissue Joint and Muscle	MENTHOL	DD&D Manufacturing Co., Ltd	531fe834-53e3-305f-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier application number: M017
TerraFreeze Pain Relief	MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE	Beyond Derma, LLC	81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677	2023-11-11	Warnings	Exact identifier application number: M017
GOLD ICE Pain Relief	MENTHOL	Eden's Answers, Inc.	a1356c39-42b9-4bd8-a873-bcd40717058b	2023-11-11	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	db6f518d-3a0e-43f8-8d19-7382d9b7ff1c	15
1544717	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray	SCD	db6f518d-3a0e-43f8-8d19-7382d9b7ff1c	15
1544717	calamine 8 % / pramoxine hydrochloride 1 % Topical Spray	SY	db6f518d-3a0e-43f8-8d19-7382d9b7ff1c	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-174-41	59779017441	116 g in 1 CANISTER (59779-174-41)	116 g	2014-01-01	0000-00-00	No	No	Current
59779-174-65	59779017465	184 g in 1 CANISTER (59779-174-65)	184 g	2019-10-28	0000-00-00	No	No	Current