FDA.reportPublic FDA data

Alocane Plus

Product NDC
68229-404
11-digit product format
682290404
Labeler code
68229
Product ID
68229-404_262e23fb-5ad9-bbde-e063-6394a90ab37b
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride and Benzalkonium Chloride
Dosage form
GEL
Route
TOPICAL
Labeler
Quest Products, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-03
Substance
LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength
4; .13 g/100mL; g/100mL
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
Alocane Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100mL
BENZALKONIUM CHLORIDE.13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
F5UM2KM3W7Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cfe8114b-df65-064b-e053-2a95a90a33f6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-404-01Alocane Plus104 mL in 1 BOTTLE, SPRAYGEL1044

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-404-01ML - Milliliter68229-404078685c3-e09b-4d18-b038-40dd6a122d3212024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-404ALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) GEL [QUEST PRODUCTS, INC.]4Current NDC, Legacy NDC, 1 package rows20241107_cfe8114b-df65-064b-e053-2a95a90a33f6.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 143 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoidal Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
application number: M017
Quatriderm Anti-itchHYDROCORTISONEOPMX LLC83e59e10-9878-e5c2-e053-2a91aa0af25e2023-12-04WarningsExact identifier
application number: M017
TACTDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLSato Pharmaceutical Inc., Ltd.b6e2ee24-69de-4dfd-9081-b9537b7a7bad2023-12-04WarningsExact identifier
application number: M017
Overnight Cold Therapy Pain ReliefMENTHOL, UNSPECIFIED FORMWalgreen Co.2cbd0966-4cf9-4271-bd53-6672b1ed2a992023-12-04WarningsExact identifier
application number: M017
Prolayed Lidocaine Male Genital DesensitizerLIDOCAINEViaDerma Distribution, Inc.9c5ad0d0-ca7a-4321-9334-f06f3f6be18f2023-12-02WarningsExact identifier
application number: M017
Liberdol Topical AnalgesicMETHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)ViaDerma Distribution, Incab52cd0e-34fa-41c7-9ce7-1183c2aff8d82023-12-01WarningsExact identifier
application number: M017
ProlayedLIDOCAINEMATRIX MIXOLOGY, INCae317876-adb1-6d13-e053-2995a90a74af2023-12-01WarningsExact identifier
application number: M017
Tact Cool JellyDIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOLSato Pharmaceutical Co., Ltd.f34872c9-91b9-49db-8e41-5b54a069284a2023-12-01WarningsExact identifier
application number: M017
SatohapMETHYL SALICYLATE, DL-CAMPHOR, L-MENTHOLSato Pharmaceutical Co., Ltd.348fde05-2797-4410-a1b2-99e64187c4fe2023-12-01WarningsExact identifier
application number: M017
Menthozen HydrogelMENTHOL, CAPSAICINProficient Rx LP85a7809e-c43f-4138-a85b-44e1b586def52023-12-01WarningsExact identifier
application number: M017
Menthozen CreamMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP66681906-c5f5-4c57-bb43-9c83cccc00622023-12-01WarningsExact identifier
application number: M017
Lidozen PatchLIDOCAINE, MENTHOLProficient Rx LPc0df4b8b-2679-4652-9144-a8db916a186b2023-12-01WarningsExact identifier
application number: M017
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LP7c300dec-cefd-4b79-a948-a917b7708a042023-12-01WarningsExact identifier
application number: M017
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP2adf3c4d-636f-4e02-b501-946b4df5f5d62023-12-01WarningsExact identifier
application number: M017
LidozenLIDOCAINE, MENTHOLProficient Rx LP488d665c-a4fe-4a69-bab3-34b2347f4b052023-12-01WarningsExact identifier
application number: M017
Thera Plus Max Strength Lidocaine Pain Relief LiquidLIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.0a228b06-0e1c-6c75-e063-6294a90a9a0e2023-11-30WarningsExact identifier
application number: M017
Thera Plus Cool and Heat Pain Relieving Gel MentholMENTHOLFourstar Group USA, Inc.0a225714-ccb1-4676-e063-6294a90aeeb22023-11-30WarningsExact identifier
application number: M017
Bloop Itch Soothing TopicalHYDROCORTISONEThree Nations Corp0b64677e-d4bf-0929-e063-6294a90af1372023-11-30WarningsExact identifier
application number: M017
Ice QuakeMENTHOLSouthern Sales & Service, Inc.7a05832f-49ac-4013-b240-4405501e45cd2023-11-29WarningsExact identifier
application number: M017
ICE MUSCLE RUB Leon M.CMENTHOLSouthern Sales & Service, Inc.4efaf347-7406-4690-8005-e7cf2e3d42222023-11-29WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68229-404-0168229040401104 mL in 1 BOTTLE, SPRAY (68229-404-01) 104 ml2021-12-030000-00-00NoNoCurrent