FDA.reportPublic FDA data

Curist 5% Lidocaine

Product NDC
72559-034
11-digit product format
725590034
Labeler code
72559
Product ID
72559-034_37b259f7-04cb-8a32-e063-6394a90a8abb
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 5%
Dosage form
SPRAY
Route
TOPICAL
Labeler
Little Pharma, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-27
Substance
LIDOCAINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
500; 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
2026-12-31
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
Curist 5% Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE500 g/100mL
PHENYLEPHRINE HYDROCHLORIDE25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal 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
2168528Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f20241a2-c5b1-f124-e053-2995a90a891bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72559-034-57Curist 5% Lidocaine177 mL in 1 CANSPRAY1773

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 88 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TattooTATTOO CREAMPerfso (HK) Co., Limited39773cab-12df-4520-e063-6294a90abc5b2025-07-08WarningsExact identifier
application number: M017
Neutrogena Sun Rescue After Sun Medicated ReliefCAMPHOR (SYNTHETIC)Kenvue Brands LLCc95c5b64-b90f-1143-e053-2a95a90aa03c2025-07-07WarningsExact identifier
application number: M017
sunmark HydrocortisoneHYDROCORTISONEStrategic Sourcing Services LLC210079e9-3d2f-4489-b468-b96b145034ed2025-07-07WarningsExact identifier
application number: M017
Relief GelLIDOCAINE HCLGood Clean Love, Inc.e5fa2265-ccb7-750c-e053-2995a90aa51e2025-07-07WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONESun Pharmaceutical Industries, Inc.09ac2749-a60f-4039-8c80-a0d2eaf50c342025-07-07WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESun Pharmaceutical Industries, Inc.2ada9ec2-1c28-4da2-8639-07b3193ffb322025-07-03WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONESun Pharmaceutical Industries, Inc.caa2fd64-e262-4d7c-ad8a-69f506feba8c2025-07-03WarningsExact identifier
application number: M017
Stopain Extra StrengthMENTHOLTroy Manufacturing, Inc.07e9a235-6d10-4407-8729-beaf936e97ad2025-07-03WarningsExact identifier
application number: M017
Blue Ice Topical Analgesic GelICE GELInternational Wholesale397cd306-078d-5b7d-e063-6294a90a8bbc2025-07-03WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINE, MENTHOLVive Health LLC236ccc6d-21b7-6153-e063-6394a90a46342025-07-02WarningsExact identifier
application number: M017
AsperFlex MAXLIDOCAINE 4% WITH MENTHOL 1%Akron Pharma Inc.ccf6172b-350a-4b78-b844-f84bf17c491f2025-07-02WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3766e3a9-94a8-4c3e-e063-6394a90aa24a2025-07-01WarningsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESun Pharmaceutical Industries, Inc.c89e3de8-7d71-485c-8fc5-2832d6024f162025-07-01WarningsExact identifier
application number: M017
Westlake Outdoor Pain and Itch RelievingLIDOCAINE 4% PAIN AND ITCH RELIEVINGWESTLAKE HB PHARMA3c563b28-4f4f-9d0c-e063-6294a90adf732025-07-01WarningsExact identifier
application number: M017
Cortizone 10 Water ResistantHYDROCORTISONEChattem, Inc.118e55e7-241f-44c4-959e-09bf6221bd772025-07-01WarningsExact identifier
application number: M017
Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.38c1616e-3b09-0669-e063-6294a90a2c862025-06-29WarningsExact identifier
application number: M017
Plantar Fasciitis CreamCAMPHORSOLALIA LLC388f33c2-2bdf-ded8-e063-6294a90aeeac2025-06-27WarningsExact identifier
application number: M017
4 Lidocaine Topical AnestheticLIDOCAINERUGBY LABORATORIES63327e57-f4c8-4ae6-9d28-cef8697bbdcc2025-06-27WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateANTI-ITCH CONTINUOUS SPRAYWal-Mart Stores, Inc.709c3bb8-5b36-4823-941a-45ddb3e431c42025-06-27WarningsExact identifier
application number: M017
Burn Relief Professional Bio-KoolLIDOCAINE - 4%Kool-Down Inc.827e9c69-4706-0ccf-e053-2991aa0aa1c12025-06-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2168528lidocaine HCl 5 % / phenylephrine HCl 0.25 % Topical SprayPSNf20241a2-c5b1-f124-e053-2995a90a891b3
2168528lidocaine hydrochloride 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Topical SpraySCDf20241a2-c5b1-f124-e053-2995a90a891b3
2168528lidocaine hydrochloride 5 % / phenylephrine hydrochloride 0.25 % Topical SpraySYf20241a2-c5b1-f124-e053-2995a90a891b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72559-034-5772559003457177 mL in 1 CAN (72559-034-57) 177 ml2024-12-26NoNoCurrent