Acetic Acid

Product NDC
50383-889
11-digit product format
503830889
Labeler code
50383
Product ID
50383-889_975ebc3f-2649-42c7-8f06-3551b94c5a7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetic Acid
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Akorn
Application
NDA012179
Marketing category
NDA
Marketing start
2010-01-22
Marketing end
0000-00-00
Substance
ACETIC ACID
Active strength
21 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-889-152025-09-10C16284748780-11030e365-554f-111a-e063-dadaa90a10e2c53fc11e-b177-446e-839d-391e1b2eacff
50383-889-152024-01-30C16284748780-11030e365-554f-111a-e063-dadaa90a10e2c53fc11e-b177-446e-839d-391e1b2eacff

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-889-15ML - Milliliter50383-8896dbe6614-0a52-4e15-9a38-8c5bb9ed81fd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETIC ACIDACTIVE INGREDIENTQ40Q9N063PACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]3
ACETIC ACIDACTIVE MOIETYQ40Q9N063PACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]3
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]3
PROPYLENE GLYCOL DIACETATEINACTIVE INGREDIENT5Z492UNF9OACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]3
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]3
ACETIC ACIDACTIVE INGREDIENTQ40Q9N063PACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.]2
ACETIC ACIDACTIVE MOIETYQ40Q9N063PACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.]2
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744ACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.]2
PROPYLENE GLYCOL DIACETATEINACTIVE INGREDIENT5Z492UNF9OACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.]2
ACETIC ACIDACTIVE INGREDIENTQ40Q9N063PACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1
ACETIC ACIDACTIVE MOIETYQ40Q9N063PACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOL DIACETATEINACTIVE INGREDIENT5Z492UNF9OACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-889ACETIC ACID SOLUTION [AKORN]8Legacy NDC20220920_c53fc11e-b177-446e-839d-391e1b2eacff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197305acetic acid 2 % Otic SolutionPSN7470a1ed-bc00-cb52-e053-2a91aa0a5c7d5
197305acetic acid 20 MG/ML Otic SolutionSCD7470a1ed-bc00-cb52-e053-2a91aa0a5c7d5
197305acetic acid 2 % Otic SolutionSY7470a1ed-bc00-cb52-e053-2a91aa0a5c7d5
197305acetic acid 2 % Otic SolutionPSN53d97ebe-fdf0-47af-ba93-a4a3327981de2
197305acetic acid 20 MG/ML Otic SolutionSCD53d97ebe-fdf0-47af-ba93-a4a3327981de2
197305acetic acid 2 % Otic SolutionSY53d97ebe-fdf0-47af-ba93-a4a3327981de2
197305acetic acid 2 % Otic SolutionPSNa8c12387-4b2b-49c2-b9c5-112ffb1339501
197305acetic acid 20 MG/ML Otic SolutionSCDa8c12387-4b2b-49c2-b9c5-112ffb1339501
197305acetic acid 2 % Otic SolutionSYa8c12387-4b2b-49c2-b9c5-112ffb1339501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-889-15503830889151 BOTTLE in 1 BOX (50383-889-15) > 15 mL in 1 BOTTLE1 bottle2010-01-220000-00-00NoNoCurrent