FDA.reportPublic FDA data

Olu Pain Management

Product NDC
76420-956
11-digit product format
764200956
Labeler code
76420
Product ID
76420-956_31b1821f-f265-221a-e063-6394a90ae56d
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine and camphor
Dosage form
PATCH
Route
CUTANEOUS
Labeler
Asclemed USA, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-01
Substance
CAMPHOR (NATURAL); LIDOCAINE
Active strength
.01; .04 g/g; g/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
Olu Pain Management
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL).01 g/g
LIDOCAINE.04 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2700664Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d4d556c1-b64b-4b8e-8e4b-4f40eda24250Available 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
76420-956-05Olu Pain Management8.5 g in 1 PATCHPATCH8.51
76420-956-05Olu Pain Management5 in 1 POUCHPATCH51
76420-956-15Olu Pain Management5 in 1 POUCHPATCH51
76420-956-15Olu Pain Management3 in 1 BOXPATCH31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-956OLU PAIN MANAGEMENT (LIDOCAINE AND CAMPHOR) PATCH [ASCLEMED USA, INC.]1Current NDC, 4 package rows20250406_d4d556c1-b64b-4b8e-8e4b-4f40eda24250.zip

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 72 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% Maximum OTC StrengthLIDOCAINECardinal Health 107, LLC975031df-d46d-4098-b1c0-1c0c92b419952025-10-20WarningsExact identifier
application number: M017
Cortizone 10 Intensive HealingHYDROCORTISONEChattem, Inc.bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c2025-10-20WarningsExact identifier
application number: M017
Sting relief padBENZOCAINE, ALCOHOLGuangdong Comfort Medical Products Co., Ltd.6e905065-10a9-1ded-e053-2a91aa0a46a12025-10-19WarningsExact identifier
application number: M017
CVS Cold and HotMENTHOLCVS Pharmacya44cec95-822a-40b6-e053-2995a90ae31c2025-10-17WarningsExact identifier
application number: M017
Sombra MaxSOMBRA MAXSombra Cosmetics Inc.41623a46-e6e7-907e-e063-6394a90afc4c2025-10-17WarningsExact identifier
application number: M017
POMADA DRAGON PAIN RELIEVINGCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATETELEVISA CONSUMER PRODUCTS USAc283291d-feaa-4f89-8fde-9e3957ea8b9f2025-10-17WarningsExact identifier
application number: M017
Ear Pain MDLIDOCAINE HYDROCHLORIDEEosera Inc78c4418f-7f0f-447f-a94f-d4c89a081af12025-10-17WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.414217c1-ff3a-b556-e063-6394a90aa5db2025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41422d04-160b-51b2-e063-6294a90ab2b22025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41427275-4c35-bbdf-e063-6294a90a14cf2025-10-16WarningsExact identifier
application number: M017
Dollar General Menthol Pain Relief Gel RollonMENTHOLDolgencorp, LLC3a9b99e2-36b8-5dcf-e063-6394a90a382d2025-10-16WarningsExact identifier
application number: M017
Quality ChoiceHYDROCORTISONEChain Drug Marketing Association, Inc.24c3eb99-92ac-658c-e063-6394a90ab51f2025-10-16WarningsExact identifier
application number: M017
DentiCalmTOPICAL ANALGESICNFUSE LLC414e6f6f-06bb-b470-e063-6294a90af3902025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.413008cd-d239-1453-e063-6394a90a74f22025-10-15WarningsExact identifier
application number: M017
PERFORM LEO EXTENSIVE PAIN RELIEFLIDOCAINE, MENTHOLPERFORM LEO LLCf993ed5f-7dbb-4e3e-addf-f65b12f5cc482025-10-15WarningsExact identifier
application number: M017
Nufabrx Lower Leg SleeveCAPSAICINNufabrx LLCb8e3e528-b7cd-e4b7-e053-2995a90a40292025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Ankle SleeveCAPSAICINNufabrx LLC013d60c7-a613-7cdf-e063-6294a90ad5842025-10-15WarningsExact identifier
application number: M017
Nufabrx Calf SleeveCAPSAICINNufabrx LLCbd9459c4-5596-746f-e053-2995a90a54002025-10-15WarningsExact identifier
application number: M017
Nufabrx Arm SleeveCAPSAICINNufabrx LLCa7993eaf-6488-a818-e053-2995a90a7ea62025-10-15WarningsExact identifier
application number: M017
Nufabrx Back WrapCAPSAICINNufabrx LLCe4f85ac8-57cb-46eb-e053-2995a90a9b1c2025-10-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2700664camphor 1 % / lidocaine 4 % Medicated PatchPSNd4d556c1-b64b-4b8e-8e4b-4f40eda242501
2700664camphor 0.01 MG/MG / lidocaine 0.04 MG/MG Medicated PatchSCDd4d556c1-b64b-4b8e-8e4b-4f40eda242501
2700664camphor 1 % / lidocaine 4 % Medicated PatchSYd4d556c1-b64b-4b8e-8e4b-4f40eda242501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-956-05764200956055 PATCH in 1 POUCH (76420-956-05) / 8.5 g in 1 PATCH5 patch2025-04-01NoNoCurrent
76420-956-15764200956153 POUCH in 1 BOX (76420-956-15) / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH3 pouch2025-04-01NoNoCurrent