FDA.reportPublic FDA data

Calaclear

Product NDC
82645-923
11-digit product format
826450923
Labeler code
82645
Product ID
82645-923_0d6cc629-bac0-1229-e063-6294a90a2610
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine Hydrochloride and Zinc Acetate
Dosage form
LOTION
Route
TOPICAL
Labeler
Pharma Nobis, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-25
Substance
PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength
10; 1 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
Calaclear
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC ACETATE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
FM5526K07AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234546Internal RxNorm lookup
1248193Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e42fccc2-1b4e-e7f3-e053-2a95a90aef39Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
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
82645-923-96Calaclear177 mL in 1 BOTTLE, PLASTICLOTION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-923CALACLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231227_e42fccc2-1b4e-e7f3-e053-2a95a90aef39.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 48 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TANZINC OXIDEBentley Laboratories, LLC7920708a-6fa7-4bc8-94ba-096e77d9d7e12024-12-27WarningsExact identifier
application number: M016
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
application number: M016
ZO Skin Health Post Procedure Recovery SystemALUMINUM ACETATEZO Skin Health, Inc.3b977415-2bf4-43a9-bb48-1eb023ca4f532024-12-27WarningsExact identifier
application number: M016
terrasil Scar RecoveryALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2f91ff-a447-9d2a-e063-6394a90a84f82024-12-26WarningsExact identifier
application number: M016
WITCH HAZELWITCH HAZELCHAIN DRUG MARKETING ASSOCIATION INCbdccee3f-0ad8-4264-a65f-ae86aed6bf032024-12-26WarningsExact identifier
application number: M016
All Over Lavender RosemaryCOLLOIDAL OAT OINTMENTTubby Todd29f46671-7467-95c9-e063-6294a90a13542024-12-23WarningsExact identifier
application number: M016
Sweet Cheeks Diaper SprayerZINC OXIDE DIAPER PASTE SPRAYTubby Todd29f4aa3c-d10e-52a5-e063-6294a90acc4b2024-12-23WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDEWALGREEN COMPANYfed3026b-3473-26fe-e053-6294a90a8aa22024-12-23WarningsExact identifier
application number: M016
CUREFINIPETROLATUM, COD LIVER OILMiramar Cosmetics, Inc DBA Miramar Labfc9211db-71aa-44d8-a00b-65f1482d39812024-12-23WarningsExact identifier
application number: M016
CUREFINIPETROLATUMMiramar Cosmetics, Inc DBA Miramar Lab6a2610ca-ca80-451f-8fed-b982443a10b92024-12-23WarningsExact identifier
application number: M016
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC453dffec-de9d-0eac-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC455a16fd-9ce5-6bef-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMTrifecta Pharmaceuticals USA LLCf1eb0ec2-98e7-13a2-e053-2a95a90a29382024-12-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDEPharmacy Value Alliance, LLC38018e3f-3778-01d1-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
DiaperRashOintmentZINC OXIDEPharmacy Value Alliance, LLC3aace6d8-d24c-00e1-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
Medicated Body PowderMENTHOLNew Pride Corpf0f0e332-cb93-42a7-e053-2995a90ac4ae2024-12-19WarningsExact identifier
application number: M016
Health Smart Medicated BodyMENTHOL AND ZINC OXIDEInternational Wholesale Inc dba Home Smart Products044870e2-ebac-a095-e063-6294a90a27512024-12-19WarningsExact identifier
application number: M016
White Rain Original PetroleumWHITE PETROLEUMINTERNATIONAL WHOLESALE INC.d6ebe00c-b692-5171-e053-2a95a90a976c2024-12-19WarningsExact identifier
application number: M016
Health Smart Original PetroleumWHITE PETROLEUMHome Smart Productsaedf746f-4c49-421d-a666-1ba02e8fb17d2024-12-19WarningsExact identifier
application number: M016
white rain Cocoa Butter Petroleum JellyWHITE PETROLATUMINTERNATIONAL WHOLESALE INC.d7068e2b-c3b2-d16d-e053-2a95a90a6dd22024-12-19WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248193CALACLEAR 1 % / 0.1 % Topical LotionPSNe42fccc2-1b4e-e7f3-e053-2a95a90aef392
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSNe42fccc2-1b4e-e7f3-e053-2a95a90aef392
1248193pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion [Calaclear]SBDe42fccc2-1b4e-e7f3-e053-2a95a90aef392
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCDe42fccc2-1b4e-e7f3-e053-2a95a90aef392
1248193Calaclear (pramoxine hydrochloride 1 % / zinc acetate 0.1 % ) Topical LotionSYe42fccc2-1b4e-e7f3-e053-2a95a90aef392
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSYe42fccc2-1b4e-e7f3-e053-2a95a90aef392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82645-923-9682645092396177 mL in 1 BOTTLE, PLASTIC (82645-923-96) 177 ml1998-03-250000-00-00NoNoCurrent