FDA.reportPublic FDA data

Refill 3

Product NDC
49687-0017
11-digit product format
496870017
Labeler code
49687
Product ID
49687-0017_2b9cfd46-fb22-a682-e063-6394a90a6ba3
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
CMC Group Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-10
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
.13; .5 g/100g; g/100g
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
Refill 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g
LIDOCAINE HYDROCHLORIDE.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui1012100

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49687-0017-0Refill 30.9 g in 1 PACKAGECREAM0.98
49687-0017-0Refill 310 in 1 BOXCREAM108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49687-0017REFILL 3 (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [CMC GROUP INC.]8Current NDC, Legacy NDC, 2 package rows20250115_e5cb395f-5037-4b0e-9c9d-2d78b5b01b25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNe5cb395f-5037-4b0e-9c9d-2d78b5b01b258
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDe5cb395f-5037-4b0e-9c9d-2d78b5b01b258
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYe5cb395f-5037-4b0e-9c9d-2d78b5b01b258

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49687-0017-04968700170010 PACKAGE in 1 BOX (49687-0017-0) / .9 g in 1 PACKAGE10 package2016-08-100000-00-00NoNoCurrent