FDA.reportPublic FDA data

SKINS DELAY Maximum Strength Lidocaine

Product NDC
81923-199
11-digit product format
819230199
Labeler code
81923
Product ID
81923-199_09e2e5e3-aaff-d4b0-e063-6294a90a1f57
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
SKINS SEXUAL HEALTH LIMITED
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-25
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
10 mg/mL
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
SKINS DELAY Maximum Strength Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
172efe5d-28b8-443c-b3f9-429669189081Available 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
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81923-199-00SKINS DELAY Maximum Strength Lidocaine1 in 1 BOXSOLUTION12
81923-199-00SKINS DELAY Maximum Strength Lidocaine15 mL in 1 CYLINDERSOLUTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81923-199SKINS DELAY MAXIMUM STRENGTH LIDOCAINE (LIDOCAINE HYDROCHLORIDE) SOLUTION [SKINS SEXUAL HEALTH LIMITED]2Current NDC, Legacy NDC, 2 package rows20231112_172efe5d-28b8-443c-b3f9-429669189081.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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81923-199-00819230199001 CYLINDER in 1 BOX (81923-199-00) / 15 mL in 1 CYLINDER1 cylinder2021-05-250000-00-00NoNoCurrent