FDA.reportPublic FDA data

Orythia Pain Relieving Lidocaine

Product NDC
75568-035
11-digit product format
755680035
Labeler code
75568
Product ID
75568-035_3893145a-25e7-9678-e063-6294a90aa827
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
PATCH
Route
TOPICAL
Labeler
Planet (Anhui) Pharmaceutical Co., Ltd.
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-25
Substance
LIDOCAINE
Active strength
40 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
Orythia Pain Relieving Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737778Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d658d495-dd2c-40b7-9446-6f10040ed55eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75568-035-01Orythia Pain Relieving Lidocaine9.1 g in 1 BAGPATCH9.11
75568-035-01Orythia Pain Relieving Lidocaine1 in 1 BOXPATCH11

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 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Pain Relieving Cream with Menthol 10%MENTHOL 10% CREAMONE2ZEE LIMITED LIABILITY COMPANYae09e93f-3988-4477-ae53-b2f3df9769fb2025-05-05WarningsExact identifier
application number: M
Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.edf07b7f-46fb-4915-b2ea-83d852617f602025-04-10WarningsExact identifier
application number: M
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb6559fb9-2dea-49c0-a274-3e77741a0ffd2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLdeecdb72-4cdb-4d6f-972f-a425a91afa5a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLdffdfa2c-a52e-4606-9b07-c8993e499f092025-03-23WarningsExact identifier
application number: M
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRL1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH KIDSDEXTROMETHORPHAN HBR-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb0fd2f2f-5cc4-4813-8f99-c78fbe8986562025-03-13WarningsExact identifier
application number: M
Menthol Pain Relief Gel PatchMENTHOL PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANYeab185d6-2a54-489d-8114-fe8088624ba42025-03-04WarningsExact identifier
application number: M
Lidocaine 4% Pain Relief Gel PatchLIDOCAINE 4% PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANY8e5a4ef4-b928-44b3-842c-92f1531af75b2025-03-03WarningsExact identifier
application number: M
gas reliefSIMETHICONEStrategic Sourcing Services LLC23005295-c5f2-4a76-8431-4a9b8d817d4d2025-01-03WarningsExact identifier
application number: M
Foster and Thrive infants Gas reliefSIMETHICONEStrategic Sourcing Services LLC824c9dff-0a26-4710-a25b-39df631d6fa62024-12-13WarningsExact identifier
application number: M
BRONCOCHEM COLD AND FLU TEAACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLb7d3f54e-59ef-4b85-a88d-b053058dc1f62024-12-12WarningsExact identifier
application number: M
HYSAN PAIN RELIEVERMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDbad73234-c204-40a8-8176-45c75ae500c82024-10-07WarningsExact identifier
application number: M
HYSAN ANALGESICMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTD99a13b0a-1d77-479e-ba99-2cfa638de3392024-10-04WarningsExact identifier
application number: M
HYSAN HUO LU MEDICATEDMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDfe9eeaff-fcbf-4287-9f17-bcf1822bf35b2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO MEDICATEDMETHYL SALICYLATEHYSAN PHARMACEUTICAL CO LTDb84c4d33-5a77-46e0-b04e-32f73967bd1c2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO HUO LUMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDcd2288c4-9909-43c1-91da-b15545b097882024-10-04WarningsExact identifier
application number: M
CLARINS - ROLL-ON DEODORANT Aluminum Chlorohydrate - Antiperspirant, Long-lasting Alcohol-freeALUMINUM CHLOROHYDRATELaboratoires Clarins412116a1-f9af-4c03-85e0-aad5738dd7972024-08-05WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRL1a3ed214-e09b-4266-b68b-39e7c3127d262024-04-22WarningsExact identifier
application number: M
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions835c3c23-fc3c-404e-8e87-5a01761267302024-02-28WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSNd658d495-dd2c-40b7-9446-6f10040ed55e1
1737778lidocaine 0.04 MG/MG Medicated PatchSCDd658d495-dd2c-40b7-9446-6f10040ed55e1
1737778lidocaine 4 % Medicated PatchSYd658d495-dd2c-40b7-9446-6f10040ed55e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75568-035-01755680035011 BAG in 1 BOX (75568-035-01) / 9.1 g in 1 BAG1 bag2025-06-25NoNoCurrent