FDA.reportPublic FDA data

Nupercainal

Product NDC
55741-402
11-digit product format
557410402
Labeler code
55741
Product ID
55741-402_c7a5c1fa-7822-8e8b-09e6-18156ad6c7bc
Type
HUMAN OTC DRUG
Nonproprietary name
Dibucaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-05-24
Marketing end
0000-00-00
Substance
DIBUCAINE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55741-402-022020-09-27C16284748780-1ab0e2407-2a01-f274-e053-dbdaa90a6471Nupercainal ®
55741-402-022020-09-25C16284748780-1ab0e2407-2a01-f274-e053-dbdaa90a6471Nupercainal ®
55741-402-022020-07-22C16284748780-1ab0e2407-2a01-f274-e053-dbdaa90a6471Nupercainal ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55741-402-02Nupercainal56.7 g in 1 TUBEOINTMENT56.73
55741-402-02Nupercainal1 in 1 BOXOINTMENT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55741-402-02GM - Gram55741-402e70f40a4-816f-4b84-98db-84a552627c0112014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DibucaineACTIVE INGREDIENTL6JW2TJG99NUPERCAINAL (DIBUCAINE) OINTMENT [DUCERE PHARMA]1
DibucaineACTIVE MOIETYL6JW2TJG99NUPERCAINAL (DIBUCAINE) OINTMENT [DUCERE PHARMA]1
acetone sodium bisulfiteINACTIVE INGREDIENT47VY054OXYNUPERCAINAL (DIBUCAINE) OINTMENT [DUCERE PHARMA]1
lanolinINACTIVE INGREDIENT7EV65EAW6HNUPERCAINAL (DIBUCAINE) OINTMENT [DUCERE PHARMA]1
light mineral oilINACTIVE INGREDIENTN6K5787QVPNUPERCAINAL (DIBUCAINE) OINTMENT [DUCERE PHARMA]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UNUPERCAINAL (DIBUCAINE) OINTMENT [DUCERE PHARMA]1
waterINACTIVE INGREDIENT059QF0KO0RNUPERCAINAL (DIBUCAINE) OINTMENT [DUCERE PHARMA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55741-402NUPERCAINAL (DIBUCAINE) OINTMENT [DR. REDDY'S LABORATORIES INC.]3Legacy NDC, 2 package rows20181220_bcf33951-d3a4-46c5-b208-56adc0011047.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238784dibucaine 1 % Rectal OintmentPSNbcf33951-d3a4-46c5-b208-56adc00110473
901429NUPERCAINAL 1 % Rectal OintmentPSNbcf33951-d3a4-46c5-b208-56adc00110473
901429dibucaine 0.01 MG/MG Rectal Ointment [Nupercainal]SBDbcf33951-d3a4-46c5-b208-56adc00110473
238784dibucaine 0.01 MG/MG Rectal OintmentSCDbcf33951-d3a4-46c5-b208-56adc00110473
238784dibucaine 1 % Rectal OintmentSYbcf33951-d3a4-46c5-b208-56adc00110473
901429Nupercainal 0.01 MG/MG Rectal OintmentSYbcf33951-d3a4-46c5-b208-56adc00110473
901429Nupercainal 1 % Rectal OintmentSYbcf33951-d3a4-46c5-b208-56adc00110473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55741-402-025574104020256.7 g in 1 TUBE56.7 gHistorical