FDA.reportPublic FDA data

Lidocaine cream

Product NDC
80489-949
Requested package NDC
80489-949-01
11-digit product format
804890949
Labeler code
80489
Product ID
80489-949_56364b0b-c371-aa7b-e063-6294a90ac8b4
Type
HUMAN OTC DRUG
Nonproprietary name
DRS Lidocaine 5% Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
OL PHARMA TECH LLC. (Drs. Pharmacy)
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-01
Substance
LIDOCAINE
Active strength
5 g/100g
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
Lidocaine cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE5 g/100g

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
1366789Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
372fe018-1e5a-9ec4-e063-6294a90a1500Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-949-01Lidocaine cream1 in 1 CARTONCREAM11
80489-949-01Lidocaine cream28.3 g in 1 TUBECREAM28.31

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 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.8e4d46d8-7084-0666-e053-2995a90ad5202025-10-21WarningsExact identifier
application number: M017
Coralite Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEUnited Exchange Corp.69aec845-3d4c-d226-e053-2991aa0afd122025-10-21WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALMCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTDf3e3b8b5-b12b-49ac-9318-b0c358b136e92025-10-21WarningsExact identifier
application number: M017
Mountain Ice Sports RecoveryMENTHOLMountainside Medical Equipment, Inc.98638529-3c17-436e-901f-c8aea52bdab62025-10-20WarningsExact identifier
application number: M017
Lip Clear Lysine PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.21a5b4fb-baed-4766-9820-5c6051c147202025-10-20WarningsExact identifier
application number: M017
Buzz Away Sting SootheMENTHOLQuantum, Inc.419e34ea-17b2-ec32-e063-6394a90a603d2025-10-20WarningsExact identifier
application number: M017
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.deb09e89-9794-89a7-e053-2a95a90abdf82025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc41571c8f-332b-f423-e063-6394a90a88972025-10-20WarningsExact identifier
application number: M017
Soothing Nerve TherapyMENTHOLWise Consumer Products40829d6b-5005-7ec9-e063-6294a90a970e2025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc4146fd51-b18c-393d-e063-6294a90a4d9a2025-10-20WarningsExact identifier
application number: M017
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366789lidocaine 5 % Rectal CreamPSN372fe018-1e5a-9ec4-e063-6294a90a15001
1366789lidocaine 50 MG/ML Rectal CreamSCD372fe018-1e5a-9ec4-e063-6294a90a15001
1366789lidocaine 5 % Rectal CreamSY372fe018-1e5a-9ec4-e063-6294a90a15001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80489-949-01804890949011 TUBE in 1 CARTON (80489-949-01) / 28.3 g in 1 TUBE1 tube2026-01-22NoNoCurrent