FDA.reportPublic FDA data

Humco Calagesic

Product NDC
82645-922
11-digit product format
826450922
Labeler code
82645
Product ID
82645-922_0d6ccb8f-d9c0-28e6-e063-6294a90a8a87
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine and Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Pharma Nobis, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-25
Substance
ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength
80; 10 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Humco Calagesic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE80 mg/mL
PRAMOXINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234532Internal RxNorm lookup
1234539Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e42fb807-8cb4-ed25-e053-2995a90a6780Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-922-96Humco Calagesic177 mL in 1 BOTTLE, PLASTICLOTION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-922HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231227_e42fb807-8cb4-ed25-e053-2995a90a6780.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 41 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Infection Protection Wound CareALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse98d1d8c-c979-49de-9bd8-cd409efff6de2025-07-11WarningsExact identifier
application number: M016
Neosporin Lip Health Overnight Renewal TherapyPETROLATUMKenvue Brands LLC0da54fe1-c99f-4a2d-9ee5-2dc24005096c2025-07-10WarningsExact identifier
application number: M016
COCOA BUTTER PETROLEUM jellyPETROLATUMSavvy Care & Cosmetics Pvt. Ltd.397d13f1-3b86-3c76-e063-6394a90a0f242025-07-09WarningsExact identifier
application number: M016
Pipette EczemaCOLLOIDAL OATMEALPipette LLC39829827-d801-f5a7-e063-6394a90a024c2025-07-09WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEWestminster Pharmaceuticals, LLC7e045b3a-f33b-4faa-ab9b-2baec6ff79242025-07-08WarningsExact identifier
application number: M016
Desitin Multi-Purpose HealingPETROLATUMKenvue Brands LLC30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab2025-07-07WarningsExact identifier
application number: M016
Astringent SolutionALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEFirst Nation Group065c895c-7d86-f1ed-e063-6394a90a3a522025-07-07WarningsExact identifier
application number: M016
Creamy PetroleumPETROLATUMSavvy Care & Cosmetics Pvt Ltd3916daee-f8d2-e3f0-e063-6294a90a38832025-07-04WarningsExact identifier
application number: M016
Exemax CreamDIMETHICONE, ALLANTOINPureTek Corporation38e79055-df84-d314-e063-6394a90ac95f2025-07-01WarningsExact identifier
application number: M016
Procure Dimethicone 5%DIMETHICONETwin Med LLC38a7e4af-997d-549e-e063-6394a90a0bd62025-06-28WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDerma Sciences Canada Inc.37eff762-1ea9-ec66-e063-6394a90a3d102025-06-19WarningsExact identifier
application number: M016
Dr.Johnes SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLCb731c55e-31ee-429f-8432-fac7c5718d832025-06-18WarningsExact identifier
application number: M016
Dr. Johne SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLC6c5adc3c-9d45-449a-ad42-f9571851cd182025-06-18WarningsExact identifier
application number: M016
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal OatmealOATMEALTHERAPLEX, LLCe51aa467-ffe7-4c6b-8588-6df8592596d42025-06-16WarningsExact identifier
application number: M016
ZIIDII Wild Yam CreamWILD YAMGuangzhou Haishi Biological Technology Co., Ltd.3733154a-4884-9988-e063-6294a90aa78c2025-06-10WarningsExact identifier
application number: M016
Aveeno Calm Plus Restore Skin Therapy BalmCOLLOIDAL OATMEALKenvue Brands LLCdbe7a2cc-9c21-2a48-e053-2a95a90a54e22025-06-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWALGREENS2017113f-d192-5fbb-e063-6294a90a83b02025-05-31WarningsExact identifier
application number: M016
AHHH Bite ReliefSODIUM BICARBONATE7827125a1e070-9228-4ec9-e063-6294a90ad78d2025-05-27WarningsExact identifier
application number: M016
SupreH Bee Venom Skin Tag Treatment LiquidSUPREH BEE VENOM SKIN TAG REMOVER LIQUIDShenzhen Xinxin Yunhai Technology Co., Ltd.35ca9836-917a-b0ac-e063-6294a90a28a22025-05-23WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Bed Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions35d2738c-dacf-7309-e063-6294a90aab4c2025-05-23WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234539CALAGESIC 8 % / 1 % Topical LotionPSNe42fb807-8cb4-ed25-e053-2995a90a67802
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSNe42fb807-8cb4-ed25-e053-2995a90a67802
1234539calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]SBDe42fb807-8cb4-ed25-e053-2995a90a67802
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCDe42fb807-8cb4-ed25-e053-2995a90a67802
1234539Calagesic (calamine 8 % / pramoxine hydrochloride 1 % ) Topical LotionSYe42fb807-8cb4-ed25-e053-2995a90a67802
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSYe42fb807-8cb4-ed25-e053-2995a90a67802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82645-922-9682645092296177 mL in 1 BOTTLE, PLASTIC (82645-922-96) 177 ml2017-11-130000-00-00NoNoCurrent