FDA.reportPublic FDA data

NDC 62135-809-05 - CIMETIDINE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
62135-809
Requested NDC
62135-809-05
Package NDCs from labels
62135-809-37, 62135-809-05, 62135-809-24
Manufacturer
Chartwell RX, LLC
Effective date
2026-02-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CIMETIDINE HYDROCHLORIDE - Chartwell RX, LLCChartwell RX, LLC2026-02-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-809-05CIMETIDINE HYDROCHLORIDE5 mL in 1 CUPSOLUTION53
62135-809-24CIMETIDINE HYDROCHLORIDE10 in 1 TRAYSOLUTION103
62135-809-24CIMETIDINE HYDROCHLORIDE2 in 1 BOXSOLUTION23
62135-809-37CIMETIDINE HYDROCHLORIDE237 mL in 1 BOTTLESOLUTION2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-809CIMETIDINE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC]2Current NDC, 4 package rows20241025_d1d73350-4e7e-428a-90a5-6000fd373a4f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-809-05ML - Milliliter62135-8093633bfe9-d26d-4e1b-8e2c-b8af6d1b97bf12024-11-05
62135-809-24ML - Milliliter62135-809df6da2b4-c290-4a2b-ba03-552dcd8efb4512024-11-05
62135-809-37ML - Milliliter62135-809ae75c93d-3cee-4aae-b887-1e9f6a2826c712024-06-10

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 42 of 270 · 5,386 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Foot CreamMENTHOLReckitt Benckiser LLC32450cbf-4ed4-402b-a30e-e08a17bba3fb2026-05-13WarningsExact identifier
unii: L7T10EIP3A
BiofreezeMENTHOLReckitt Benckiser LLCa227213b-e89f-7144-e053-2a95a90a7e742026-05-13WarningsExact identifier
unii: L7T10EIP3A
BiofreezeMENTHOLReckitt Benckiser LLC00bb462a-27d0-6f74-e063-6394a90a90ec2026-05-13WarningsExact identifier
unii: L7T10EIP3A
BioFreeze Dry StickMENTHOLReckitt Benckiser LLC26d62cd2-9209-8cca-e063-6394a90a20282026-05-13WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Colorless Roll-OnMENTHOLReckitt Benckiser LLCa8d59d45-0e85-43d1-affd-bbe922c4acb12026-05-13WarningsExact identifier
unii: L7T10EIP3A
Biofreeze ColorlessMENTHOLReckitt Benckiser LLC939dbbc3-71ec-4990-840e-7c9b8d4305622026-05-13WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Flexible Relief StripMENTHOLReckitt Benckiser LLC6ec26bae-e395-49aa-969e-8c653d6f0b272026-05-13WarningsExact identifier
unii: L7T10EIP3A
Biofreeze FoamMENTHOLReckitt Benckiser LLC890191e8-99ad-489c-8f21-2592f3d319362026-05-13WarningsExact identifier
unii: L7T10EIP3A
Valtrum TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELaboratorios Quantium LLCf3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e2026-05-13WarningsExact identifier
unii: L7T10EIP3A
Smart Care PEACH BELLINI 2 HAND SANITIZERS 1.35 FL OZETHYL ALCOHOLAshtel Studios Inc.80e475a5-97d7-4ad9-9be1-0ccdb42e6fce2026-05-12WarningsExact identifier
unii: 3K9958V90M
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsExact identifier
unii: L7T10EIP3A
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
unii: L7T10EIP3A
Theracare Cold Therapy Pain ReliefMENTHOLVeridian Healthcare51a5a043-07b6-1c96-e063-6394a90aa9262026-05-12WarningsExact identifier
unii: L7T10EIP3A
Cepacol Extra Strength Sore Throat cherryBENZOCAINE AND MENTHOLReckitt Benckiser LLC941e36dd-d8d0-4e5c-8585-10e8f06bf8f02026-05-12WarningsExact identifier
unii: L7T10EIP3A
Cepacol Extra Strength Sore Throat honey lemonBENZOCAINE AND MENTHOLReckitt Benckiser LLCd771095b-7de3-48f3-a125-8bc76e7d17782026-05-12WarningsExact identifier
unii: L7T10EIP3A
Smart Care Luxury Hand Sanitizer Whispering WoodsALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ab5d03-1199-75c8-e063-6294a90ab6712026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA BLOSSOM HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.408ba9aa-6e03-48fe-a08e-799dbaa3408c2026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care ROSEWATER HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.0a5a21d9-6832-47a2-a4bb-83781aaa61aa2026-05-12WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.