FDA.reportPublic FDA data

Alocane Plus

Product NDC
68229-300
11-digit product format
682290300
Labeler code
68229
Product ID
68229-300_3a24cc92-30d8-d5f1-e063-6294a90a537e
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
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
.13; 4 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

Additional Listing Data#

Finished product
Yes
Brand name base
Alocane Plus
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui2375042, 2587646

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68229-300-022020-02-03C16284748780-19d75b9d1-2b47-f424-e053-dadaa90a57ceAlocane ® Plus
68229-300-022020-01-31C16284748780-19d75b9d1-2b47-f424-e053-dadaa90a57ceAlocane ® Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-300-01Alocane Plus3.55 mL in 1 DOSE PACKGEL3.5510
68229-300-02Alocane Plus50 in 1 BOXGEL5010
68229-300-03Alocane Plus1 in 1 CARTONGEL110
68229-300-03Alocane Plus59 mL in 1 TUBEGEL5910
68229-300-04Alocane Plus946 mL in 1 BOTTLE, PUMPGEL94610
68229-300-05Alocane Plus3.55 mL in 1 DOSE PACKGEL3.558
68229-300-06Alocane Plus48 in 1 CARTONGEL488

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-300-01EA - Each68229-300379cbe87-939f-4066-8e28-789c4c3430db12021-01-08
68229-300-02EA - Each68229-300b520af95-ef09-4734-9392-dcb3d85fe98112021-01-08
68229-300-03ML - Milliliter68229-30027207190-a638-4f5a-b3df-27cde1c29d3b12021-09-07
68229-300-04ML - Milliliter68229-30074748392-6b14-42fc-8c52-9340ed8a8bb312021-09-07
68229-300-05ML - Milliliter68229-300e75b92b2-0797-472a-8c2e-1f676e76b8ff22022-02-07
68229-300-06ML - Milliliter68229-300110ad54a-6f0b-4007-9433-4a41ec8d354322022-02-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W7ALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41AALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
BenzalkoniumACTIVE MOIETY7N6JUD5X6YALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
LidocaineACTIVE MOIETY98PI200987ALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L0ALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438UALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
ChlorphenesinINACTIVE INGREDIENTI670DAL4SZALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
Dimethyl IsosorbideINACTIVE INGREDIENTSA6A6V432SALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
Hydroxyethyl Cellulose (5500 MPA.S AT 2%)INACTIVE INGREDIENTM825OX60H9ALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
PropanediolINACTIVE INGREDIENT5965N8W85TALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) OINTMENT [QUEST PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-300ALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) GEL [QUEST PRODUCTS, INC.]9Current NDC, Legacy NDC, 5 package rows20240110_24538037-1d74-48a0-b909-98ecc57651fe.zip
68229-300ALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) GEL [QUEST PRODUCTS LLC]7Current NDC, Legacy NDC, 2 package rows20241107_b3ec09b9-7511-0895-e053-2a95a90a7840.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2587646ALOCANE plus 4 % / 0.13 % Topical GelPSN24538037-1d74-48a0-b909-98ecc57651fe10
2375042benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % Topical GelPSN24538037-1d74-48a0-b909-98ecc57651fe10
2587646benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.04 MG/MG Topical Gel [Alocane Plus]SBD24538037-1d74-48a0-b909-98ecc57651fe10
2375042benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.04 MG/MG Topical GelSCD24538037-1d74-48a0-b909-98ecc57651fe10
2587646Alocane Plus (benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % ) Topical GelSY24538037-1d74-48a0-b909-98ecc57651fe10
2375042benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % Topical GelSY24538037-1d74-48a0-b909-98ecc57651fe10
2587646ALOCANE plus 4 % / 0.13 % Topical GelPSNb3ec09b9-7511-0895-e053-2a95a90a78408
2375042benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % Topical GelPSNb3ec09b9-7511-0895-e053-2a95a90a78408
2587646benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.04 MG/MG Topical Gel [Alocane Plus]SBDb3ec09b9-7511-0895-e053-2a95a90a78408
2375042benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.04 MG/MG Topical GelSCDb3ec09b9-7511-0895-e053-2a95a90a78408
2587646Alocane Plus (benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % ) Topical GelSYb3ec09b9-7511-0895-e053-2a95a90a78408
2375042benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % Topical GelSYb3ec09b9-7511-0895-e053-2a95a90a78408

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68229-300-01682290300013.55 mL in 1 DOSE PACK3.55 mlHistorical
68229-300-026822903000250 DOSE PACK in 1 BOX (68229-300-02) > 3.55 mL in 1 DOSE PACK (68229-300-01) 50 dose pack2013-12-110000-00-00NoNoCurrent
68229-300-03682290300031 TUBE in 1 CARTON (68229-300-03) / 59 mL in 1 TUBE1 tube2020-03-010000-00-00NoNoCurrent
68229-300-0468229030004946 mL in 1 BOTTLE, PUMP (68229-300-04) 946 ml2021-07-090000-00-00NoNoCurrent
68229-300-05682290300053.55 mL in 1 DOSE PACK3.55 mlHistorical
68229-300-066822903000648 DOSE PACK in 1 CARTON (68229-300-06) > 3.55 mL in 1 DOSE PACK (68229-300-05) 48 dose pack2020-11-120000-00-00NoNoCurrent