FDA.reportPublic FDA data

Calamine Plus

Product NDC
79481-0615
11-digit product format
794810615
Labeler code
79481
Product ID
79481-0615_42660d75-8443-3e31-e063-6294a90a284d
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine Plus Pramoxine HCL
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Meijer Distribution Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-25
Substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
5; 10; 79.5 mg/g; mg/g; mg/g
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXIDE RED5 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g
ZINC OXIDE79.5 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
88AYB867L5Internal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03c46823-0b1f-4101-e063-6294a90aaf94Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
79481-0615-1Calamine Plus116 g in 1 CANISTERAEROSOL, SPRAY1163

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0615CALAMINE PLUS (CALAMINE PLUS PRAMOXINE HCL) AEROSOL, SPRAY [MEIJER DISTRIBUTION INC.]2Current NDC, 1 package rows20241016_03c46823-0b1f-4101-e063-6294a90aaf94.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 147 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BODY ACTION PRODUCTS Endless Love for MenBENZOCAINEPRODUCT MAX GROUP INCd0fa792d-dc04-4bdf-a22d-dea896beae5b2023-11-10WarningsExact identifier
application number: M017
Endless Love For MenBENZOCAINEBody Action Products, Inc4e89cd3a-ecad-44c3-acb3-6d0810add8c02023-11-10WarningsExact identifier
application number: M017
BODY ACTION PRODUCTS Higher Control Male ClimaxBENZOCAINEPRODUCT MAX GROUP INC3c7fa73b-abe8-4a8d-951c-4e785d6e812c2023-11-10WarningsExact identifier
application number: M017
Uber NumbLIDOCAINE HYDROCHLORIDEUBERScientific, LLC65a319a6-89d2-44c9-81d5-30327f9948cb2023-11-10WarningsExact identifier
application number: M017
Uber NumbLIDOCAINE HYDROCHLORIDEUBERScientific, LLC768f3f0e-1add-404f-b869-00a9f35ad34a2023-11-10WarningsExact identifier
application number: M017
Zcaine Fast Acting AnestheticLIDOCAINEPHI, Incd072243f-6ba6-4ab6-8ebf-a2381fa9c2df2023-11-09WarningsExact identifier
application number: M017
Plum Smooth Plumb Numb GeleeLIDOCAINEUniversal Companies, Inc.6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e2023-11-09WarningsExact identifier
application number: M017
Sonacaine Topical Anesthetic With MentholLIDOCAINEFilltech USA, LLCca54c6da-4bf2-4e63-ba7f-a69c4f9c431a2023-11-09WarningsExact identifier
application number: M017
Bed Bug Instant Bite ReliefLIDOCAINEP.F. Harris Mfg. Co. LLC7f472fd0-5605-4cc6-b4b2-1267e815255c2023-11-09WarningsExact identifier
application number: M017
Valtrum Aerobic SportsSALICYLIC ACID MENTHOL CAMPHOR (NATURAL)LABORATORIOS QUANTIUM LLC33f2491e-c1f2-4e5a-acbe-8ace844b88d62023-11-09WarningsExact identifier
application number: M017
Valtrum Topical Analgesic Roll OnSALICYLIC ACID MENTHOL CAMPHOR (NATURAL)LABORATORIOS QUANTIUM LLC28167e2a-9afb-44e7-90c7-9577df9504b62023-11-09WarningsExact identifier
application number: M017
Satohap Cool TypeCAMPHOR, MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.fe07a00a-2699-44d3-887d-bd068948ad7b2023-11-07WarningsExact identifier
application number: M017
Hims Delay WipesBENZOCAINE WIPESHims Inc.adbead3d-dca0-4919-b688-44c88f779e5a2023-11-07WarningsExact identifier
application number: M017
Bakers Best Maximum Strength Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLBaker's Best Health Products, LLC9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d2023-11-06WarningsExact identifier
application number: M017
BAKERS BEST Pain Relief with Pure Hemp Seed OilLIDOCAINE HYDROCHLORIDE, MENTHOLBAKER'S BEST HEALTH PRODUCTS, INC.ae54c234-bfe4-4a74-b293-db7efda7884b2023-11-06WarningsExact identifier
application number: M017
Arth RX Topical AnalgesicMETHYL NICOTINATE, CAPSAICINHCD Salesa7b3b9b4-b1c4-4e51-8e3a-c84f64c756092023-11-06WarningsExact identifier
application number: M017
BAKERS BEST Arthritis Pain Relief Cream with Hemp and LavenderHISTAMINE DIHYDROCHLORIDEBAKER'S BEST HEALTH PRODUCTS, INC.03ec87c5-6669-4afb-8d9c-c8dc9907495d2023-11-06WarningsExact identifier
application number: M017
DOCTORS TOUCH Erase The PainMENTHOLDOCTOR'S CHOICE MEDICAL, LLCfe9ce2c7-d6af-4dad-b6e6-5049a9e091b02023-11-06WarningsExact identifier
application number: M017
RadiaGuard Advanced Radiation ReliefLIDOCAINE HYDROCHLORIDESMOOTH SIDE, INC21205087-5a2e-41a5-be40-30cba28954082023-11-06WarningsExact identifier
application number: M017
BLUE SPRING Foot and Leg ComfortMENTHOLACA MANAGEMENT LLC5f52218d-eea4-4640-b820-84c077ab98ba2023-11-06WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0615-179481061501116 g in 1 CANISTER (79481-0615-1) 116 g2023-08-25NoNoCurrent