FDA.reportPublic FDA data

GNP Lidocaine

Product NDC
46122-614
11-digit product format
461220614
Labeler code
46122
Product ID
46122-614_450fdf4f-ee89-c3e3-e063-6294a90a68f3
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCl
Dosage form
CREAM
Route
TOPICAL
Labeler
AMERISOURCE BERGEN
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-24
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
4 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
GNP Lidocaine
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010895

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
46122-614-102023-12-07C16284748780-1d6a99b39-e734-a426-e053-dadaa90af4c2GNP Lidocaine Pain Releiveing Creme
46122-614-102022-01-28C16284748780-1d6a99b39-e734-a426-e053-dadaa90af4c2GNP Lidocaine Pain Releiveing Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-614-10GNP LidocaineMaximum Strength1 in 1 CARTONCREAM15
46122-614-10GNP LidocaineMaximum Strength76.5 g in 1 BOTTLE, PLASTICCREAM76.55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-614-10GM - Gram46122-614db702816-5d58-4324-aaab-de4b2c260a8312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-614GNP LIDOCAINE MAXIMUM STRENGTH (LIDOCAINE HCL) CREAM [AMERISOURCE BERGEN]4Current NDC, Legacy NDC, 2 package rows20241225_9f559c20-c9ac-e480-e053-2a95a90a8fce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010895lidocaine HCl 4 % Topical CreamPSN9f559c20-c9ac-e480-e053-2a95a90a8fce5
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD9f559c20-c9ac-e480-e053-2a95a90a8fce5
1010895lidocaine hydrochloride 4 % Topical CreamSY9f559c20-c9ac-e480-e053-2a95a90a8fce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-614-10461220614101 BOTTLE, PLASTIC in 1 CARTON (46122-614-10) / 76.5 g in 1 BOTTLE, PLASTIC2020-02-240000-00-00NoNoCurrent