HemAway

Product NDC
54473-336
11-digit product format
544730336
Labeler code
54473
Product ID
54473-336_315a0b74-9363-a429-e063-6394a90adc0d
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Melaleuca, Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-04
Substance
LIDOCAINE
Active strength
1.5 g/30g
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
HemAway
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE1.5 g/30g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1366789

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-336-02HemAway1 in 1 BOXCREAM13
54473-336-31HemAway30 g in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-336HEMAWAY (LIDOCAINE) CREAM [MELALEUCA, INC.]3Current NDC, Legacy NDC, 2 package rows20250409_cf842adf-fcd7-2c8c-e053-2995a90adea6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366789lidocaine 5 % Rectal CreamPSNcf842adf-fcd7-2c8c-e053-2995a90adea63
1366789lidocaine 50 MG/ML Rectal CreamSCDcf842adf-fcd7-2c8c-e053-2995a90adea63
1366789lidocaine 5 % Rectal CreamSYcf842adf-fcd7-2c8c-e053-2995a90adea63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-336-01544730336011 TUBE in 1 BOX (54473-336-01) > 30 g in 1 TUBE (54473-336-30) 1 tube2020-08-040000-00-00NoNoCurrent
54473-336-02544730336021 TUBE in 1 BOX (54473-336-02) / 30 g in 1 TUBE (54473-336-31) 1 tube2020-08-04NoNoHistorical
54473-336-315447303363130 g in 1 TUBE30 gHistorical