FDA.reportPublic FDA data

Lidocaine Phenylephrine

Product NDC
73581-910
11-digit product format
735810910
Labeler code
73581
Product ID
73581-910_5a72a190-212a-411e-e063-6394a90a08c2
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Phenylephrine
Dosage form
SPRAY
Route
TOPICAL
Labeler
YYBA CORP
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-02
Substance
LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; .25 g/100mL; g/100mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC]
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
Lidocaine Phenylephrine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE5 g/100mL
PHENYLEPHRINE HYDROCHLORIDE.25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2590656Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5a72a190-2129-411e-e063-6394a90a08c2Available on FDA.report

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 6 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREPARATION H MEDICATED WIPESWITCH HAZELHaleon US Holdings LLC8d9961f0-1ecf-d7fb-b6b4-856d636d68e12026-03-17WarningsExact identifier
application number: M015
Crane Safety BurnLIDOCAINECrane Safety LLC96d81566-6321-731e-e053-2995a90ad07d2026-03-16WarningsExact identifier
application number: M015
Signature Lidocaine Pain Relief Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4c56b3b3-33b3-a50e-e063-6394a90a955f2026-03-06WarningsExact identifier
application number: M015
WowDay Medicated Hemorrhoidal Flushable WipesMEDICATED HEMORRHOIDAL FLUSHABLE WIPESWowDay LLC4c603b27-4835-bc40-e063-6394a90a8ea22026-03-06WarningsExact identifier
application number: M015
Numb Fast HemorrhoidalLIDOCAINEOasis Plus LLCa00ffed7-8034-4cc0-87c4-3c793c1bcd6e2026-03-03WarningsExact identifier
application number: M015
Curist Lidocaine ReliefLIDOCAINE 5%Little Pharma, Inc.f562b57d-6592-93fa-e053-2995a90ae3e02026-03-02WarningsExact identifier
application number: M015
Therapain PlusMENTHOL ROLL-ONEpic Laboratories, LLC0249cfdf-b7c4-f27d-e063-6294a90aaa262026-03-02WarningsExact identifier
application number: M015
Liposomal Hemorrhoid MasterLIDOCAINE , PHENYLEPHRINE HCLClinical Resolution Laboratory, Inc.a1e15d2a-44b6-4d9c-89c2-0ff12285724e2026-03-02WarningsExact identifier
application number: M015
Equate Hemorrhoid ReliefLIDOCAINEWalmart Inc.48646860-ed5d-62a0-e063-6394a90abb232026-03-01WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELThe Kroger Co.bbf2efd7-f181-403b-ac5f-695f7ba158752026-02-27Warnings, Adverse reactionsExact identifier
application number: M015
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
application number: M015
Megababe Fun Gal Stuff AntifungalCLOTRIMAZOLEMegababe LLCc599d27b-fdb0-465f-9e43-13d32c520a922026-02-25WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELBetter Living Brands, LLC0355edab-b6f7-4e59-bce1-cf6a8897b9892026-02-24Warnings, Adverse reactionsExact identifier
application number: M015
Zinc Oxide and MentholZINC OXIDE, MENTHOLAkron Formulations India Private Limited4b84556c-521f-eebd-e063-6394a90a8e1e2026-02-23WarningsExact identifier
application number: M015
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
application number: M015
OxifyLIDOCAINE 5%Weeks & Leo Compnay, INC.41d9d0b4-33e7-7e05-e063-6394a90a10112026-02-17WarningsExact identifier
application number: M015
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
application number: M015
Gniby - LIDOCAINE ANORECTAL HEMORRHOIDALNUMBINGPutian Licheng District Zhijiancheng Trading Co., Ltd.4a5f59f1-c11a-e2eb-e063-6394a90a3e272026-02-10WarningsExact identifier
application number: M015
Numb MasterLIDOCAINEClinical Resolution Laboratory, Inc.0921c824-a8a9-4707-a480-c750192983f52026-02-09WarningsExact identifier
application number: M015
Signature Care HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCIBetter Living Brands, LLC3c8b43f3-6e1e-499e-ba71-ffdf836f67432026-02-05WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73581-910-0173581091001150 mL in 1 BOTTLE (73581-910-01) 150 ml2026-09-02NoNoCurrent