Calm and Correct Serum with Lidocaine

Product NDC
76348-725
11-digit product format
763480725
Labeler code
76348
Product ID
76348-725_34b77b18-b7e3-c3e3-e063-6294a90aead8
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 3 percent
Dosage form
LIQUID
Route
TOPICAL
Labeler
Renu Laboratories, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-02
Substance
LIDOCAINE
Active strength
1.5 g/50mL
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
Calm and Correct Serum with Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE1.5 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui2607527

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-725-012025-05-12C16284748780-12cef2736-67f1-d83d-e063-dadaa90ab31fCALM and CORRECT PAIN RELIEF SERUM
76348-725-012025-01-30C16284748780-12cef2736-67f1-d83d-e063-dadaa90ab31fCALM and CORRECT PAIN RELIEF SERUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-725-01Calm and Correct Serum with Lidocaine1 in 1 BOXLIQUID12
76348-725-50Calm and Correct Serum with Lidocaine50 mL in 1 BOTTLE, PUMPLIQUID502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-725CALM AND CORRECT SERUM WITH LIDOCAINE (LIDOCAINE 3 PERCENT) LIQUID [RENU LABORATORIES, LLC]2Current NDC, Legacy NDC, 2 package rows20250514_ddcf1c2e-2f67-44d7-e053-2a95a90a812b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2607527lidocaine 3 % Topical SolutionPSNddcf1c2e-2f67-44d7-e053-2a95a90a812b2
2607527lidocaine 30 MG/ML Topical SolutionSCDddcf1c2e-2f67-44d7-e053-2a95a90a812b2
2607527lidocaine 3 % Topical SolutionSYddcf1c2e-2f67-44d7-e053-2a95a90a812b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76348-725-01763480725011 BOTTLE, PUMP in 1 BOX (76348-725-01) / 50 mL in 1 BOTTLE, PUMP (76348-725-50) 2022-08-020000-00-00NoNoCurrent
76348-725-507634807255050 mL in 1 BOTTLE, PUMP50 mlHistorical