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 57 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LenzaPro FlexLIDOCAINE/MENTHOLSOLA Pharmaceuticalsba498f1d-460b-f4e6-e053-2995a90a57552025-12-08WarningsExact identifier
application number: M017
LidaFlexLIDOCAINESOLA Pharmaceuticalsb9e49529-13b4-1b0b-e053-2995a90adc7a2025-12-08WarningsExact identifier
application number: M017
Rugby Menthol Hot Cold PatchMENTHOLRUGBY LABORATORIESc68d29c2-9b56-4994-e053-2a95a90ae60e2025-12-08WarningsExact identifier
application number: M017
Neuracin Topical GelNEURACIN TOPICAL ANALGESIC GELSOLA Pharmaceuticalsc3166926-30c2-2128-e053-2a95a90a0bf22025-12-08WarningsExact identifier
application number: M017
TriceptinLIDOCAINE / MENTHOL / METHYL SALICYLATESOLA Pharmaceuticalsef1b98ab-d2db-038c-e053-2995a90a94b42025-12-08WarningsExact identifier
application number: M017
SynoFlex PatchSYNOFLEX PATCHSola Pharmaceuticalsde2042c4-6c5e-7365-e053-2a95a90ada2a2025-12-08WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1NICOTINE TRANSDERMAL PATCHESPCHEERY LLC457c860b-091d-8350-e063-6294a90a2f982025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC457c9bd6-2e72-03e5-e063-6394a90a558c2025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMP ROLL-ONCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC3e552afc-9305-8825-e063-6294a90a1afe2025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC457d89aa-4a84-94a6-e063-6294a90a20c02025-12-08WarningsExact identifier
application number: M017
Gold Bond Medicated Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLGold Bond Co LLC4a2bd277-47dd-4ae6-9b4b-e0ae9aad226b2025-12-05WarningsExact identifier
application number: M017
Orajel for Cold Sores Double Medicated, CreamBENZOCAINE AND WHITE PETROLATUMChurch & Dwight Co., Inc.b8699a40-8464-ca02-e053-2995a90a42602025-12-05WarningsExact identifier
application number: M017
Thompson Hydrocortisone 1%HYDROCORTISONEThompsonf8740314-7e1f-815e-e053-6294a90a6eae2025-12-05WarningsExact identifier
application number: M017
JUST CBD SOOTHING UNSCENTEDLIDOCAINE HCLJust Brands LLC453f44e2-9e5b-8695-e063-6394a90a43892025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC453fa1a7-368c-ae50-e063-6294a90a55072025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC4540221f-cf9f-9b6a-e063-6294a90adec32025-12-05WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLGold Bond Co LLC3e84375f-95d3-420c-b222-02a7574125922025-12-04WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLCb3ec09b9-7511-0895-e053-2a95a90a78402025-12-04WarningsExact identifier
application number: M017
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLCd240e9b8-3506-42ab-8a50-05e8d3fac4ff2025-12-04WarningsExact identifier
application number: M017
BLT Skin CreamBENZOCAINE, LIDOCAINE, TETRACAINEM2B Pharma LLC9dc5db9d-9e0a-cd28-e053-2995a90a6bf72025-12-04WarningsExact 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