FDA.reportPublic FDA data

DG Health

Product NDC
75712-200
11-digit product format
757120200
Labeler code
75712
Product ID
75712-200_297a2bcb-9db2-5f05-e063-6394a90a33fc
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Cl, Lidocaine HCl
Dosage form
SPRAY
Route
TOPICAL
Labeler
Dollar General Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-11
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
1.3; 40 mg/mL; mg/mL
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
DG Health
Brand name suffix
Maximum Strength Pain Relieving Cleansing
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL
LIDOCAINE HYDROCHLORIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui2047877

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
75712-200-012023-02-07C16284748780-1f386c649-d925-0266-e053-dadaa90a7c1aDrug Facts - DG Health Maximum Strength Pain Relieving Cleansing
75712-200-012023-01-30C16284748780-1f386c649-d925-0266-e053-dadaa90a7c1aDrug Facts - DG Health Maximum Strength Pain Relieving Cleansing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75712-200-01DG HealthMaximum Strength Pain Relieving Cleansing148 mL in 1 BOTTLESPRAY1483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75712-200DG HEALTH MAXIMUM STRENGTH PAIN RELIEVING CLEANSING (BENZALKONIUM CL, LIDOCAINE HCL) SPRAY [DOLLAR GENERAL CORPORATION]3Current NDC, Legacy NDC, 1 package rows20241220_64f69315-77a3-49dc-940d-efd7a29c6645.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SprayPSN64f69315-77a3-49dc-940d-efd7a29c66453
2047877benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCD64f69315-77a3-49dc-940d-efd7a29c66453
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SpraySY64f69315-77a3-49dc-940d-efd7a29c66453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75712-200-0175712020001148 mL in 1 BOTTLE (75712-200-01) 148 ml2022-02-110000-00-00NoNoCurrent