FDA.reportPublic FDA data

Alocane Max

Product NDC
68229-406
11-digit product format
682290406
Labeler code
68229
Product ID
68229-406_4de08098-5946-ba6e-e063-6294a90a8dbe
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride and Benzalkonium Chloride
Dosage form
GEL
Route
TOPICAL
Labeler
Quest Products LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-01
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
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
Alocane Max
Listing expiration
2027-12-31

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2375042Internal RxNorm lookup
2587646Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a33f9a9-1fdc-7cdf-e063-6294a90adca1Available 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
68229-406-01Alocane Max75 mL in 1 TUBEGEL757
68229-406-02Alocane Max1 in 1 CARTONGEL17
68229-406-03Alocane Max118 mL in 1 TUBEGEL1187
68229-406-05Alocane Max1 in 1 CARTONGEL17
68229-406-06Alocane Max3.4 mL in 1 PACKETGEL3.47
68229-406-07Alocane Max24 in 1 CARTONGEL247
68229-406-08Alocane Max110 mL in 1 TUBEGEL1107
68229-406-09Alocane Max1 in 1 CARTONGEL17
68229-406-10Alocane Max59 mL in 1 TUBEGEL597
68229-406-11Alocane Max1 in 1 CARTONGEL17
68229-406-85Alocane Max251.4 mL in 1 TUBEGEL251.47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-406-02ML - Milliliter68229-4061d96aaae-85fa-4d02-af55-4e0e1508ec5812023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-406ALOCANE MAX (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) GEL [QUEST PRODUCTS LLC]4Current NDC, 11 package rows20250212_0a33f9a9-1fdc-7cdf-e063-6294a90adca1.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 142 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Poli-AHYDROCORTISONE ACETATESato Pharmaceutical Co., Ltd.e27a3840-d9de-4bd0-ad75-8a151bd12b832023-11-28WarningsExact identifier
application number: M017
Sheffield Arthritis and Muscle Pain ReliefCAPSICUM OLEORESINSheffield Pharmaceuticals LLC724b9870-e86a-4087-ba78-8c944ce3baa62023-11-28WarningsExact identifier
application number: M017
Dr Sheffield Muscle Rub CreamMUSCLE RUB CREAMSheffield Pharmaceuticals LLC60d1d826-a53e-42e5-bc30-1b2c2690445b2023-11-28WarningsExact identifier
application number: M017
Thera Plus Cold Therapy Pain Relieving MentholMENTHOLFourstar Group USA, Inc.0a462c91-5300-e282-e063-6394a90a4cc22023-11-27WarningsExact identifier
application number: M017
UtaSprayMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLCc641ab11-cd00-4e23-ace7-8178739084f02023-11-21WarningsExact identifier
application number: M017
Top Medicated OilCAMPHOR, MENTHOL, METHYL SALICYLATEBig 5 Nutrition LLCb2f0d1e1-7d03-434e-be39-9f980459690c2023-11-21WarningsExact identifier
application number: M017
BT Pain Relief BalmMETHYL SALICYLATE, MENTHOL, CAMPHORBig 5 Nutrition LLC50112419-c934-4d3a-9ea6-9b089f516a6d2023-11-21WarningsExact identifier
application number: M017
BT Pain ReliefMENTHOL, METHYL SALICYLATEBig 5 Nutrition LLC91324910-27cf-424f-9e9b-6173f2d7acbf2023-11-21WarningsExact identifier
application number: M017
Dit Da ShuiMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLC5d45cb48-3e88-4d58-81d2-6f88d7a821342023-11-20WarningsExact identifier
application number: M017
Herbal BalmMETHYL SALICYLATE, MENTHOL ANDBig 5 Nutrition LLC09b3b86d-3434-428b-b0a8-e8dfd7c0b52a2023-11-20WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesb505769e-9c46-3cf3-e053-2a95a90a4df92023-11-17WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesd6523993-d781-cdbc-e053-2a95a90af1912023-11-17WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.4d91baf3-9655-4786-93b8-aa0d93fe0bf92023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPMENTHOLKOBAYASHI Healthcare International, Inc.7ef03298-6623-4cf4-b21f-74b2ffc11c6e2023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.436e8578-b609-4b45-8f84-0d111140fda62023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOLKOBAYASHI Healthcare International, Inc.08dcfa78-7332-4f19-90d7-fdd7d446848a2023-11-16WarningsExact identifier
application number: M017
Totally Fun After SunLIDOCAINE HCLMJ Products Association, LLC965a2a29-914c-4ad0-b25f-5df3c30da3932023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f2023-11-15WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.b44beac3-1d20-434f-9a79-4fab1ac687912023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC79ad55eb-b59d-4bb8-88e3-3b51e10a7f282023-11-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2587646ALOCANE plus 4 % / 0.13 % Topical GelPSN0a33f9a9-1fdc-7cdf-e063-6294a90adca17
2375042benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % Topical GelPSN0a33f9a9-1fdc-7cdf-e063-6294a90adca17
2587646benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.04 MG/MG Topical Gel [Alocane Plus]SBD0a33f9a9-1fdc-7cdf-e063-6294a90adca17
2375042benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.04 MG/MG Topical GelSCD0a33f9a9-1fdc-7cdf-e063-6294a90adca17
2587646Alocane Plus (benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % ) Topical GelSY0a33f9a9-1fdc-7cdf-e063-6294a90adca17
2375042benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % Topical GelSY0a33f9a9-1fdc-7cdf-e063-6294a90adca17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68229-406-016822904060175 mL in 1 TUBE75 mlHistorical
68229-406-02682290406021 TUBE in 1 CARTON (68229-406-02) / 75 mL in 1 TUBE (68229-406-01) 1 tube2023-11-15NoNoCurrent
68229-406-0368229040603118 mL in 1 TUBE118 mlHistorical
68229-406-05682290406051 TUBE in 1 CARTON (68229-406-05) / 118 mL in 1 TUBE (68229-406-03) 1 tube2023-11-15NoNoCurrent
68229-406-06682290406063.4 mL in 1 PACKET3.4 mlHistorical
68229-406-076822904060724 PACKET in 1 CARTON (68229-406-07) / 3.4 mL in 1 PACKET (68229-406-06) 24 packet2023-11-15NoNoCurrent
68229-406-0868229040608110 mL in 1 TUBE110 mlHistorical
68229-406-09682290406091 TUBE in 1 CARTON (68229-406-09) / 110 mL in 1 TUBE (68229-406-08) 1 tube2025-02-10NoNoCurrent
68229-406-106822904061059 mL in 1 TUBE59 mlHistorical
68229-406-11682290406111 TUBE in 1 CARTON (68229-406-11) / 59 mL in 1 TUBE (68229-406-10) 1 tube2025-12-04NoNoCurrent
68229-406-8568229040685251.4 mL in 1 TUBE (68229-406-85) 251.4 ml2025-12-15NoNoCurrent