FDA.reportPublic FDA data

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
IngredientStrength
FERRIC OXIDE RED5 mg/g
ZINC OXIDE75 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1K09F3G675Internal UNII lookup
SOI2LOH54ZInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1544717Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3cd18f96-34f7-3f2c-e063-6294a90a3b7eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-959-01Calamine Plus Pramoxine HCl116 g in 1 CANAEROSOL, SPRAY1161

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 71 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATE 1%Unifirst First Aid Corporationf2b46d69-1c21-5ae9-e053-2a95a90a60a92025-10-24WarningsExact identifier
application number: M017
Extra StrengthMENTHOL AND METHYL SALICYLATESaje Natural Business Inc.87d872b3-3231-d0f2-e053-2995a90a9d982025-10-24WarningsExact identifier
application number: M017
Coralite Muscle and Joint Pain ReliefCAMPHOR, MENTHOL, AND MEHTYL SALICYLATEUnited Exchange Corporation78edeeb8-3e3c-64bb-e053-2a91aa0a7bbc2025-10-24WarningsExact identifier
application number: M017
Coralite Odor Free Pain ReliefLIDOCAINEUnited Exchange Corporation7966d9f2-22f9-a900-e053-2991aa0aba552025-10-24WarningsExact identifier
application number: M017
Signature Care Cold and HotMENTHOL, AND METHYL SALICYLATESafeway Inc.ab201023-e3dc-52ec-e053-2995a90a1f182025-10-24WarningsExact identifier
application number: M017
HealthWise Medicated Cold Hot 5% PatchMENTHOLVeridian Healthcare15aef56f-cd25-05ac-e063-6394a90a07bb2025-10-23WarningsExact identifier
application number: M017
AlivioLIDOCAINEAmerise Pharmaceuticals LLCeb3a98f1-c875-4f08-8b4b-44e22626b6092025-10-23WarningsExact identifier
application number: M017
Pain Relieveing Gel-PatchLIDOCAINEBullet point LLC41d507c4-ad37-2686-e063-6394a90aae5b2025-10-23WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP98fa9a34-0e1e-0997-e053-2a95a90ac77d2025-10-23WarningsExact identifier
application number: M017
Coralite Pain Relief HotMENTHOL AND CAPSAICINUnited Exchange Corporation78eb133d-01bb-6466-e053-2991aa0accc02025-10-23WarningsExact identifier
application number: M017
AmericaineBENZOCAINEInsight Pharmaceuticals LLC4fd14452-0285-40c4-b835-36935c2056b22025-10-23WarningsExact identifier
application number: M017
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bc1c0c-63d5-0d41-e063-6394a90a341b2025-10-22WarningsExact identifier
application number: M017
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bd0769-6ba0-d0d5-e063-6294a90af7c92025-10-22WarningsExact identifier
application number: M017
Coralite Extra Strength Pain Relief Sleeve KneeMENTHOLUnited Exchange Corp.aa5873bd-af64-41cc-8f16-7714c56bca962025-10-22WarningsExact identifier
application number: M017
Family Care Muscle RubCAMPHOR, MENTHOL, AND METHYL SALICYLATEUnited Exchange Corp.63006bb5-76e8-eb64-e053-2991aa0a95ad2025-10-22WarningsExact identifier
application number: M017
Winco Cold and Hot Medicated Patch LargeMENTHOLWINCO FOODS, LLCaf0d86c4-f74e-2dbe-e053-2a95a90a74c12025-10-22WarningsExact identifier
application number: M017
Coralite Cold and HotMENTHOLUnited Exchange Corp.064a6149-a0e2-8a73-e063-6394a90a79532025-10-22WarningsExact identifier
application number: M017
Topical AnalgesicMENTHOLYoungevity International Inc.b4693947-f5b3-6fd3-e053-2995a90ab5812025-10-22WarningsExact identifier
application number: M017
PAIN RELIEVINGLIDOCAINEMedhome Pharma Inc41cb1135-84e0-0c9a-e063-6294a90ada962025-10-22WarningsExact identifier
application number: M017
KINKANAMMONIA, CAMPHOR (NATURAL), MENTHOLKINKANDO CO., LTD .f2c0f3e1-792b-4798-bf6d-acd1bbefa2612025-10-21WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSN3cd18f96-34f7-3f2c-e063-6294a90a3b7e1
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD3cd18f96-34f7-3f2c-e063-6294a90a3b7e1
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySY3cd18f96-34f7-3f2c-e063-6294a90a3b7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81522-959-0181522095901116 g in 1 CAN (81522-959-01) 116 g2025-08-12NoNoCurrent