FDA.reportPublic FDA data

Pain Relieving Cream Lidocaine

Product NDC
69396-139
11-digit product format
693960139
Labeler code
69396
Product ID
69396-139_2a937989-4dc6-58d5-e063-6294a90a4ea9
Type
HUMAN OTC DRUG
Nonproprietary name
Benzyl alcohol, Lidocaine HCI
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-23
Substance
BENZYL ALCOHOL; LIDOCAINE HYDROCHLORIDE
Active strength
10; 4 g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relieving Cream Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZYL ALCOHOL10 g/100g
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLKG8494WBH, V13007Z41A
Rxcui1926513

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-139-03Pain Relieving Cream Lidocaine1 in 1 BOXCREAM13
69396-139-03Pain Relieving Cream Lidocaine85 g in 1 TUBECREAM853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-139PAIN RELIEVING CREAM LIDOCAINE (BENZYL ALCOHOL, LIDOCAINE HCI) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]3Current NDC, 2 package rows20250101_039a2036-54b2-cf28-e063-6294a90a8ce6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1926513benzyl alcohol 10 % / lidocaine HCl 4 % Topical CreamPSN039a2036-54b2-cf28-e063-6294a90a8ce63
1926513benzyl alcohol 0.1 ML/ML / lidocaine hydrochloride 40 MG/ML Topical CreamSCD039a2036-54b2-cf28-e063-6294a90a8ce63
1926513benzyl alcohol 10 % / lidocaine HCl 4 % Topical CreamSY039a2036-54b2-cf28-e063-6294a90a8ce63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-139-03693960139031 TUBE in 1 BOX (69396-139-03) / 85 g in 1 TUBE1 tube2023-08-23NoNoCurrent