FDA.reportPublic FDA data

Olu Pain Management

Product NDC
85534-0102
11-digit product format
855340102
Labeler code
85534
Product ID
85534-0102_5a14e251-150e-18e1-e063-6294a90a1509
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine and camphor
Dosage form
PATCH
Route
CUTANEOUS
Labeler
HAWAII REPACK, INC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-24
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
31ed3d82-ba12-46b2-b0ec-7e5e019efc10Available 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 126 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Anti ItchHYDROCORTISONEL. Perrigo Companyecd6d841-40b9-42c9-825d-d172cd04824d2024-10-03WarningsExact identifier
application number: M017
Gold Bond Medicated Original Strength BodyMENTHOLNavajo Manufacturing Company Inc.f71d598c-92c3-d6fd-e053-6394a90a97d72024-10-03WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafeway9e663535-4acc-4b37-acae-8c17517c5a3d2024-10-03WarningsExact identifier
application number: M017
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLC849c60fc-e455-4c50-8adf-ac59c0ee785b2024-10-03WarningsExact identifier
application number: M017
rexall anti itch maximum strength reliefHYDROCORTISONEDolgencorp, LLC894cf9ab-693a-4210-96df-605947f51b632024-10-03WarningsExact identifier
application number: M017
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI070000d7-7d4d-439b-9a91-851ba7c027e62024-10-03WarningsExact identifier
application number: M017
hydrocortisone anti itchHYDROCORTISONEH E Ba1a9fed8-4938-48b5-81f1-d3942d534bb82024-10-03WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFIef9ea069-9b97-4bf5-aaac-deb85334dbd02024-10-03WarningsExact identifier
application number: M017
Basic Care HydrocortisoneHYDROCORTISONEAmazon.com Services LLC7fa13ab4-5f2d-4a48-816f-1b22d5f757b22024-10-03WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEA-S Medication Solutionsdc388dc1-0c4f-4bf1-8a12-fa39892317bc2024-10-02WarningsExact identifier
application number: M017
Geliga MuscularMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAfb2beb08-0ad6-a89d-e053-6294a90aa6fe2024-10-02WarningsExact identifier
application number: M017
Geliga Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAda28097f-4b5c-6159-e053-2a95a90a7d962024-10-02WarningsExact identifier
application number: M017
CircatrixCAPSAICINPureTek Corporationcd3b1256-2df8-dc26-e053-2a95a90ad0492024-10-02WarningsExact identifier
application number: M017
DermacinRx Penetral CreamCAPSAICINPureTek Corporation1e343a52-6071-3230-e054-00144ff8d46c2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEBorden Company (Private) Limited36abfc2c-d424-4df8-968d-866342c96a562024-10-02WarningsExact identifier
application number: M017
Eagle BalmCAMPHOR MENTHOLEagle Indo Pharma, PT87614869-9675-2c76-e053-2a95a90a48a92024-10-02WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedd9a93daa-4e24-6690-e053-2a95a90a147c2024-10-02WarningsExact identifier
application number: M017
Eagle Extra StrengthMENTHOL METHYL SALICYLATEBorden Company (Private) Limited5e02fbe3-5bc7-430e-b661-3a760ddd8fe02024-10-02WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEBorden Company (Private) Limitedc62a4313-2c07-5f58-e053-2995a90a083a2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEEagle Indo Pharma, PTe272ec90-3cd9-5b70-e053-2a95a90a1df42024-10-02WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85534-0102-0855340102003 POUCH in 1 BOX (85534-0102-0) / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH3 pouch2026-07-22NoNoCurrent
85534-0102-1855340102015 PATCH in 1 POUCH (85534-0102-1) / 8.5 g in 1 PATCH5 patch2026-07-22NoNoCurrent