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 122 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
anti itchHYDROCORTISONEMeijer, Inc.2db7bcab-acb8-48ad-8cd1-842ff7765ed92024-10-23WarningsExact identifier
application number: M017
NATUREANCE MIRACLEMENTHOLEROS GLOBAL CORPec1a2a1f-a38d-9c59-e053-2a95a90ad2682024-10-23WarningsExact identifier
application number: M017
Profoot Plantar Relief StripsCAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.65e142d8-da21-4c55-9faf-b387cb6c2c0e2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.cc011b79-2761-40f7-8142-88f8e30a179a2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEProfoot, Inc.06f82bde-41a1-35f6-e063-6394a90a64372024-10-23WarningsExact identifier
application number: M017
Deep Cover Bug Bite ReliefBENZOCAINEMorrisons Outdoors, LLC25010dd6-fb48-8ee7-e063-6394a90aee6c2024-10-21WarningsExact identifier
application number: M017
Evel Knievels Natural Choice Pain ReliefMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.4576656c-4b6e-6965-7665-6c52756c65732024-10-21WarningsExact identifier
application number: M017
berkley and jensen anti itchHYDROCORTISONEBJWC5cc6e4f6-c62d-4923-9726-9dbc569a3f492024-10-19WarningsExact identifier
application number: M017
DG Health Hydrocortisone Maximum StrengthHYDROCORTISONEDolgencorp Inc2cc792b8-dce6-4178-bd6d-63ba268b77472024-10-19WarningsExact identifier
application number: M017
Careland Hydrogel Pain Relief PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.e970070c-1c3b-49f0-8298-e6c5ebbf50a02024-10-18WarningsExact identifier
application number: M017
Fruit of the Earth Cool Blue Aloe Mist ContinuousLIDOCAINE HYDROCHLORIDEFruit Of The Earth, Inc.d4caae4c-efba-2453-e053-2995a90a5e5f2024-10-18WarningsExact identifier
application number: M017
CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-RelievingLIDOCAINE HCLCVS Pharmacyf0f1969d-10e0-76ee-e053-2995a90a73362024-10-17WarningsExact identifier
application number: M017
Wong To Yick External AnalgesicCAMPHOR MENTHOL METHYL SALICYLATEWong To Yick Wood Lock Ointment Ltd16a21af4-6bc0-4ae1-aa3b-1da84c8286e22024-10-17WarningsExact identifier
application number: M017
Wong To Yick External AnalgesicCAMPHOR MENTHOL METHYL SALICYLATEWicsun Trading Inc0b4bd444-b3c1-47aa-a7e3-f16c923261242024-10-17WarningsExact identifier
application number: M017
Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCLLIDOCAINEFruit of the Earth, Inc.c7a833bd-7457-73a3-e053-2a95a90ac53f2024-10-17WarningsExact identifier
application number: M017
Wegmans Aloe After Sun Gel with Lidocaine HCl External AnalgesicLIDOCAINE HYDROCHLORIDEWEGMANS FOOD MARKETS INCf70bc438-7ed8-f74d-e053-6394a90a2b3f2024-10-16WarningsExact identifier
application number: M017
EQUATE Sunburn relief with Aloe After SunLIDOCAINEWal-Mart Stores Incc25e1288-7ac6-41fc-ab65-26c379f288a72024-10-16WarningsExact identifier
application number: M017
Genuine First Aid Insect Sting Relief Pad 1 ctBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.b119ba37-0ee1-851a-e053-2995a90a85b12024-10-15WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWalgreen Company1a587e6e-88d1-4b01-abad-9a365dc64a4d2024-10-15WarningsExact identifier
application number: M017
TopCare Everyday After Sun CoolingLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATES LLCbaff7293-e1a3-d1f2-e053-2995a90a93ca2024-10-15WarningsExact 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