FDA.reportPublic FDA data

Alcaine

Product NDC
0998-0016
11-digit product format
009980016
Labeler code
0998
Product ID
0998-0016_5468200d-d85e-4e90-928b-84a91e05185b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
proparacaine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
ANDA080027
Marketing category
ANDA
Marketing start
1973-10-19
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
Alcaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPARACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU96OL57GOY
Rxcui1191013, 1191026

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
0998-0016-15Alcaine15 mL in 1 BOTTLESOLUTION/ DROPS1511
0998-0016-15Alcaine1 in 1 CARTONSOLUTION/ DROPS111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0998-0016-15ML - Milliliter0998-0016a138be10-e9e1-4c7a-b2a9-05cdfaeb1f0612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPARACAINE HYDROCHLORIDEACTIVE INGREDIENTU96OL57GOYALCAINE (PROPARACAINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]2
PROPARACAINEACTIVE MOIETYB4OB0JHI1XALCAINE (PROPARACAINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ALCAINE (PROPARACAINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALCAINE (PROPARACAINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBALCAINE (PROPARACAINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IALCAINE (PROPARACAINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RALCAINE (PROPARACAINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0998-0016ALCAINE (PROPARACAINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]11Current NDC, Legacy NDC, 2 package rows20240721_0c0fa0bf-977d-4539-b8dc-54c187c5b094.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191026Alcaine 0.5 % Ophthalmic SolutionPSN0c0fa0bf-977d-4539-b8dc-54c187c5b09411
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN0c0fa0bf-977d-4539-b8dc-54c187c5b09411
1191026proparacaine hydrochloride 5 MG/ML Ophthalmic Solution [Alcaine]SBD0c0fa0bf-977d-4539-b8dc-54c187c5b09411
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD0c0fa0bf-977d-4539-b8dc-54c187c5b09411
1191026Alcaine 0.5 % Ophthalmic SolutionSY0c0fa0bf-977d-4539-b8dc-54c187c5b09411
1191026Alcaine 5 MG/ML Ophthalmic SolutionSY0c0fa0bf-977d-4539-b8dc-54c187c5b09411
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY0c0fa0bf-977d-4539-b8dc-54c187c5b09411
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN9a67a989-ec6b-4a26-e053-2a95a90a826d4
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD9a67a989-ec6b-4a26-e053-2a95a90a826d4
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY9a67a989-ec6b-4a26-e053-2a95a90a826d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0998-0016-15009980016151 BOTTLE in 1 CARTON (0998-0016-15) / 15 mL in 1 BOTTLE1 bottle1973-10-190000-00-00NoNoCurrent