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 115 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Health Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATE	Natural Essentials, Inc.	f7198485-3d68-41d2-b9b9-f932a0649310	2024-12-04	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE PLUS	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Hisamitsu America, Inc.	364924d3-fac3-4f4e-9b40-decd4ec48245	2024-12-03	Warnings	Exact identifier application number: M017
Bite and Itch	DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	Weeks & Leo Co., Inc.	0a4d471b-c3f3-0a6a-e063-6394a90ad57b	2024-12-03	Warnings	Exact identifier application number: M017
Menthol	AMISH ORIGINS MEDICATED	Amish Origins LLC	547abe39-3af3-4d70-99dd-caf8d67feda2	2024-12-03	Warnings	Exact identifier application number: M017
Meijer Small Cold-Hot Medicated Patches	MENTHOL	Meijer Distribution Inc	be6012d6-2062-45ba-8fc4-abf14cff5845	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	acdd5622-a9a7-4cc3-877e-57efea23303f	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas DEEP Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu America, Inc.	a4ddb2b9-d023-4c8c-9285-93d51f93207d	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE PLUS	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Hisamitsu America, Inc.	ea5b4a7f-d47d-4dbd-9288-c01329e387e5	2024-12-03	Warnings	Exact identifier application number: M017
Hempvana Ultra Strength Pain Relief - Overnight	LIDOCAINE	Telebrands Corp	1030d478-6805-6579-e063-6294a90a0c76	2024-12-02	Warnings	Exact identifier application number: M017
Campho-Phenique Cold Sore Treatment	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare LLC	106c0bb2-f2e2-4255-867d-d09ff6a5a2e6	2024-12-02	Warnings	Exact identifier application number: M017
Campho-Phenique Antiseptic	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare LLC	82edaef0-0709-4ae1-a664-c9c5adb91ee1	2024-12-02	Warnings	Exact identifier application number: M017
Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll On	THERMACARE CAPSAICIN ROLL ON	Clarion Brands LLC	2850f7e7-41dd-f5f9-e063-6394a90ae519	2024-12-02	Warnings	Exact identifier application number: M017
BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	2ec1cf79-c341-4b79-9047-ce29f0dff419	2024-11-29	Warnings	Exact identifier application number: M017
TheraCare Pain Relieving Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	242204d3-efc7-f7a9-e063-6294a90a5af1	2024-11-27	Warnings	Exact identifier application number: M017
Walgreens Flexible Pain Relieving Lidocaine	LIDOCAINE, MENTHOL	Walgreen Co.	6f070fa3-a61a-4523-a470-ab58bf9400a3	2024-11-27	Warnings	Exact identifier application number: M017
Benadryl Original Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	920c50cb-9bdd-4a36-bb3d-c2559db73327	2024-11-26	Warnings	Exact identifier application number: M017
Universal ARTHRITIS and SPORT	METHYL SALICYLATE, CAPSICUM	Universal Distribution Center LLC	884907a8-c884-4cce-ac10-9d4848fdba3e	2024-11-22	Warnings	Exact identifier application number: M017
Universal ARTHRITIS and SPORT	METHYL SALICYLATE, CAPSICUM	Universal Distribution Center LLC	7f067e95-e01c-4b9a-a02e-0af097beb18c	2024-11-22	Warnings	Exact identifier application number: M017
Universal ARTHRITIS and SPORT	METHYL SALICYLATE, CAPSICUM	Universal Distribution Center LLC	9ece9b3a-0092-4c1c-a913-c2fefcd70541	2024-11-22	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