FDA.reportPublic FDA data

NDC 49427-434 - Hexa-Caine

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
49427-434
Package NDCs from labels
49427-434-04
Manufacturer
Pegasus Laboratories, Inc. | Swati Spentose Private Limited
Effective date
2021-12-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hexa-Caine - Pegasus Laboratories, Inc. | Swati Spentose Private LimitedPegasus Laboratories, Inc. | Swati Spentose Private Limited2021-12-28OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49427-434-04Hexa-Caine118 mL in 1 BOTTLE, SPRAYSPRAY1184
49427-434-04Hexa-Caine12 in 1 CARTONSPRAY124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49427-434HEXA-CAINE (LIDOCAINE HCL) SPRAY [PEGASUS LABORATORIES, INC.]42 package rows20211229_914fbb95-1280-41eb-93d7-e2f6d2ce96d2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AHEXA-CAINE ANTI-ITCH (LIDOCAINE HCL) SPRAY [PEGASUS LABORATORIES, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987HEXA-CAINE ANTI-ITCH (LIDOCAINE HCL) SPRAY [PEGASUS LABORATORIES, INC.]1

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 33 of 33 · 653 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lydexa 4.12%LIDOCAINE HYDROCHLORIDEPureTek Corporationaa1c9d39-1283-8c6b-e053-2a95a90af5b52022-03-02Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEInternational Medication Systems, Limited2c48cfac-81eb-4a81-8590-bc94574dd4c32021-12-14Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
unii: V13007Z41A
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC6702589d-6a15-40fe-877a-a9a1a4ad0f7a2020-11-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEProficient Rx LP5b4b36dd-da60-47de-a2c1-517a52ab35492020-05-01Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.b8803e38-fe30-48ec-9399-013f2880e0eb2020-04-09Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
DermacinRx LidotralLIDOCAINE HYDROCHLORIDEPureTek Corporation23efec58-67cc-418d-85f5-7ef156443cbf2019-02-04Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
EhaLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.09835640-55c3-4bfa-9ad3-15d37f06e8712018-11-01WarningsExact identifier
unii: V13007Z41A
SunBurnt PLUS Pain ReliefLIDOCAINE HYDROCHLORIDEWelmedix LLC dba Welmedix Consumer Healthcare6363c695-f801-407d-a4e1-b0d9cfa0a2732018-03-13WarningsExact identifier
unii: V13007Z41A
UnburnLIDOCAINE HYDROCHLORIDEWater-Jel Technologies0c504ba8-8a40-43dd-8c68-62ed106b32a22017-12-01WarningsExact identifier
unii: V13007Z41A
UnburnLIDOCAINE HYDROCHLORIDEWater-Jel Technologies40164231-1556-4714-9e27-9d41e3c714472017-11-30WarningsExact identifier
unii: V13007Z41A
First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies25ebf112-8ac3-4402-9a87-00e454ab7efa2017-11-30WarningsExact identifier
unii: V13007Z41A
CVS Pain Relieving First Aid AntisepticLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy454b1773-eda8-5610-e054-00144ff88e882017-01-04WarningsExact identifier
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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