HEB Calaclear

Product NDC
37808-040
11-digit product format
378080040
Labeler code
37808
Product ID
37808-040_0ccb3da3-cd22-5dd2-e063-6294a90ab069
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Acetate and Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
H E B
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
HEB Calaclear
Listing expiration
2026-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5d576794-88d1-484a-e053-2991aa0aa479Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
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
37808-040-96HEB Calaclear177 mL in 1 BOTTLE, PLASTICLOTION1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-040HEB CALACLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [H E B]4Current NDC, Legacy NDC, 1 package rows20231219_5d576794-88d1-484a-e053-2991aa0aa479.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 40 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EIGHT HOUR SKIN FRAGRANCE FREEPETROLATUMREVLONb61d6e2e-18dd-37d2-e053-2a95a90af57b2025-08-01WarningsExact identifier
application number: M016
Vigority Wild Yam CreamESTRIOL CREAMFOUNDATION COMMERCE INC39b2bef7-46c5-9ad5-e063-6294a90ae9832025-07-30WarningsExact identifier
application number: M016
Rugby Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONRugby Laboratories9af3a740-ef97-26ce-e053-2a95a90a0ee12025-07-28WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Soothing Bath TreatmentOATMEALKenvue Brands LLCe7eb10b7-3950-49cb-ba73-11e7581b6be92025-07-25WarningsExact identifier
application number: M016
ProCure SkinGuardPETROLATUM 49.9%Twin Med LLC3a1721f6-1bb0-cd47-e063-6394a90a148e2025-07-25WarningsExact identifier
application number: M016
ProCure HydroCerinPETROLATUM 33%Twin Med LLC3ab7248d-b914-9fdd-e063-6294a90ac4c82025-07-24WarningsExact identifier
application number: M016
AD PREVENT OriginalAD PREVENT ORIGINALWellSpring Pharmaceutical Corporationcf73246e-81c1-42e9-a107-dc6c99cf7d012025-07-24WarningsExact identifier
application number: M016
Dimethicone 1 Skin ProtectantDIMETHICONEUniversal Distribution Center LLC2c5b96b9-24d6-4223-a63d-fe83d7c023682025-07-24WarningsExact identifier
application number: M016
Dr Butlers Soothing IncontinenceMINERAL OIL 59.8%, PETROLATUM 36.0%Beyond Health PA3a9d3796-fd05-fe57-e063-6294a90a0ac62025-07-23WarningsExact identifier
application number: M016
A and D plus EVITAMIN A, D AND E OINTMENTDerma Sciences Canada Inc.35aca592-bfd0-652f-e063-6394a90ac53e2025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMDerma Sciences Canada Inc.3a895e6c-da8d-db9b-e063-6394a90ace402025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLEUM JELLYNeilMed Pharmaceuticals Inc.36bbbb1e-78e9-98f6-e063-6294a90a66d12025-07-21WarningsExact identifier
application number: M016
Mountain Ice EczemaCOLLOIDAL OATMEALMountainside Medical Equipment, Inc.1a91f33e-dd85-4d5a-b61c-e460a507e2922025-07-21WarningsExact identifier
application number: M016
Our Eczema RemedyCOLLOIDAL OATMEALFewer Better Things3a755b4c-47c8-9ca5-e063-6394a90af84a2025-07-21WarningsExact identifier
application number: M016
Aveeno DAILY MOISTURIZINGDIMETHICONEKenvue Brands LLC54a13b85-32b5-439d-a27a-8fba2cf442512025-07-16WarningsExact identifier
application number: M016
ProCure Moisture Barrier1% DIMETHICONE, 12% ZINC OXIDETwin Med LLC3988c83b-d4eb-1f09-e063-6394a90a45ad2025-07-14WarningsExact identifier
application number: M016
Avalon Organics Antidandruff ConditionerSALICYLIC ACIDThe Hain Celestial Group, Inc.66db1071-022a-aa19-e053-2a91aa0a8e392025-07-11WarningsExact identifier
application number: M016
Avalon Organics AntidandruffSALICYLIC ACIDThe Hain Celestial Group, Inc.66c7f730-64f3-4eef-e053-2a91aa0a42252025-07-11WarningsExact identifier
application number: M016
terrasil Infection Protection Wound Care Maximum StrengthALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions9e7843e2-ca69-40f5-a4ce-da6b03ebe7f72025-07-11WarningsExact identifier
application number: M016
terrasil Skin RepairALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions92a23c7f-6b89-49cb-93e2-49ab7a85c86d2025-07-11WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-040-9637808004096177 mL in 1 BOTTLE, PLASTIC (37808-040-96) 177 ml2017-10-260000-00-00NoNoCurrent