FDA.reportPublic FDA data

Acetic Acid

Product NDC
52817-816
11-digit product format
528170816
Labeler code
52817
Product ID
52817-816_2a4574f2-001a-ad0a-e063-6394a90a98f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetic Acid
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
TruPharma, LLC
Application
ANDA040607
Marketing category
ANDA
Marketing start
2020-06-01
Substance
ACETIC ACID
Active strength
20.65 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETIC ACID20.65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ40Q9N063P
Rxcui197305

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52817-816-15Acetic Acid15 mL in 1 BOTTLESOLUTION152
52817-816-15Acetic Acid1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-816-15ML - Milliliter52817-81603567882-4160-4c16-8ea4-b074335594ae12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-816ACETIC ACID SOLUTION [TRUPHARMA, LLC]2Current NDC, Legacy NDC, 2 package rows20241228_0c5ebd59-0e98-4ea1-b279-9202a19f6dbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197305acetic acid 2 % Otic SolutionPSNc1c28375-9b03-4590-9d39-ab28403da93d3
197305acetic acid 20 MG/ML Otic SolutionSCDc1c28375-9b03-4590-9d39-ab28403da93d3
197305acetic acid 2 % Otic SolutionSYc1c28375-9b03-4590-9d39-ab28403da93d3
197305acetic acid 2 % Otic SolutionPSN0c5ebd59-0e98-4ea1-b279-9202a19f6dbf2
197305acetic acid 2 % Otic SolutionPSNf9b4d18b-25f3-604f-e053-6394a90a55312
197305acetic acid 20 MG/ML Otic SolutionSCD0c5ebd59-0e98-4ea1-b279-9202a19f6dbf2
197305acetic acid 20 MG/ML Otic SolutionSCDf9b4d18b-25f3-604f-e053-6394a90a55312
197305acetic acid 2 % Otic SolutionSY0c5ebd59-0e98-4ea1-b279-9202a19f6dbf2
197305acetic acid 2 % Otic SolutionSYf9b4d18b-25f3-604f-e053-6394a90a55312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-816-15528170816151 BOTTLE in 1 CARTON (52817-816-15) / 15 mL in 1 BOTTLE1 bottle2020-06-010000-00-00NoNoCurrent