FDA.reportPublic FDA data

Proparacaine Hydrochloride

Product NDC
24208-730
11-digit product format
242080730
Labeler code
24208
Product ID
24208-730_46f24726-30f8-471b-b0be-b7da62d88bfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA040074
Marketing category
ANDA
Marketing start
1995-09-29
Substance
PROPARACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Local Anesthesia [PE], Local Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Proparacaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPARACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU96OL57GOY
Rxcui1191013

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ba0893a-4390-4124-b66b-ffd4f2b29a0eProduct name220260305

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-730-06Proparacaine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS111
24208-730-06Proparacaine Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-730-06ML - Milliliter24208-7304aacb9e2-351b-4cc5-bfee-c49a6d2147d612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPARACAINE HYDROCHLORIDEACTIVE INGREDIENTU96OL57GOYPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
PROPARACAINEACTIVE MOIETYB4OB0JHI1XPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
WATERINACTIVE INGREDIENT059QF0KO0RPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
PROPARACAINE HYDROCHLORIDEACTIVE INGREDIENTU96OL57GOYPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
PROPARACAINEACTIVE MOIETYB4OB0JHI1XPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-730PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]11Current NDC, Legacy NDC, 2 package rows20231031_b699f838-8b69-4bac-953b-ea8822ec19fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf26113
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf26113
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf26113
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSNb699f838-8b69-4bac-953b-ea8822ec19fc11
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCDb699f838-8b69-4bac-953b-ea8822ec19fc11
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSYb699f838-8b69-4bac-953b-ea8822ec19fc11
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN68a84d3f-a8f8-13ee-e053-2991aa0a75925
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD68a84d3f-a8f8-13ee-e053-2991aa0a75925
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY68a84d3f-a8f8-13ee-e053-2991aa0a75925
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN509fed7b-637b-418c-93cd-19f49ba8740c2
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN522987a1-d52e-4819-9ce4-53fd17c126c22
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD509fed7b-637b-418c-93cd-19f49ba8740c2
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD522987a1-d52e-4819-9ce4-53fd17c126c22
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY509fed7b-637b-418c-93cd-19f49ba8740c2
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY522987a1-d52e-4819-9ce4-53fd17c126c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-730-06242080730061 BOTTLE, DROPPER in 1 CARTON (24208-730-06) / 15 mL in 1 BOTTLE, DROPPER1995-09-290000-00-00NoNoCurrent