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 74 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nufabrx Medicine Infused SocksCAPSAICINNufabrx LLC00d7d5bf-ee03-e73d-e063-6394a90a5d942025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Elbow SleeveCAPSAICINNufabrx LLC27ef3ef0-2f98-6672-e063-6294a90aeca42025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Wrist SleeveCAPSAICINNufabrx LLC22572cf9-fc0c-d327-e063-6394a90a21862025-10-15WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWALGREENSeff77965-dc7f-49af-e053-2995a90a1a972025-10-14WarningsExact identifier
application number: M017
Pleasure Balm Kama SutraBENZOCAINECosmetic Enterprises Ltdf370e3c4-65ca-4f3c-a5aa-70e198e681a22025-10-14WarningsExact identifier
application number: M017
Vanicream HC Anti-ItchHYDROCORTISONEPharmaceutical Specialties, Inc.28b06507-27a5-2cb1-e054-00144ff8d46c2025-10-14WarningsExact identifier
application number: M017
TrilogelLIDOCAINE HYDROCHLORIDETrifluent Pharma LLC22af7d63-6a56-4a38-a95b-0f88410b23cb2025-10-14WarningsExact identifier
application number: M017
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.40c63645-8ed3-82b3-e063-6294a90a52672025-10-13WarningsExact identifier
application number: M017
CramergesicMENTHOL, METHYL SALICYLATEThe Hygenic Company, LLCd0ffde7a-6942-74fc-e053-2a95a90a484a2025-10-13WarningsExact identifier
application number: M017
TricylateMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATETrifluent Pharma LLC4869b63a-e01e-4a79-a493-7a1b4d3e914b2025-10-13WarningsExact identifier
application number: M017
Doloflex Pain ReliefMENTHOL, METHYL SALICYLATEUnited Health & Beauty Corp32a830cc-04d3-102e-e063-6294a90a1cad2025-10-12WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINENanjing Anxing Medical Technology Co., Ltd.40c9b132-57ce-865e-e063-6394a90a20802025-10-10WarningsExact identifier
application number: M017
KinesysZINC OXIDEWilc Healthcare Inca32b44c3-eda0-48ea-95fc-250a2c2396ca2025-10-10WarningsExact identifier
application number: M017
Te-Fu Recovery MassageMENTHOL, METHYL SALICYLATEWasatch Product Development7bc2989f-dfb6-e8af-e053-2991aa0a0bf22025-10-10WarningsExact identifier
application number: M017
Anti-itchHYDROCORTISONEMedline Industries, LPb0947381-c0db-4253-ab40-3d45603ae65d2025-10-09WarningsExact identifier
application number: M017
Kalaya Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe2452c4b-2548-497f-828b-5d960402522a2025-10-08WarningsExact identifier
application number: M017
Kalaya Pain Relief 6X with ArnicaPAIN RELIEF CREAMAvaria Health & Beauty Corp60198d2e-4de3-3fa0-e053-2a91aa0afaf72025-10-08WarningsExact identifier
application number: M017
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp9b9b7cad-a5e2-4445-856b-4aa439d77a802025-10-08WarningsExact identifier
application number: M017
KALAYA FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpd5021e6d-f29f-446b-874c-bdcabd9cf4f62025-10-08WarningsExact identifier
application number: M017
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe0c9f22a-165a-4558-ba3c-8592f1bd00162025-10-08WarningsExact 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