FDA.reportPublic FDA data

AeroTab Non-Aspirin

Product NDC
55305-126
11-digit product format
553050126
Labeler code
55305
Product ID
55305-126_2f179527-4b42-8e0d-e063-6394a90a6257
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN 500MG ES
Dosage form
TABLET
Route
ORAL
Labeler
Aero Healthcare
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-31
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AeroTab Non-Aspirin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55305-126-022025-02-26C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets
55305-126-042025-02-26C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets
55305-126-052025-02-26C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets
55305-126-022025-01-30C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets
55305-126-042025-01-30C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets
55305-126-052025-01-30C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55305-126-01AeroTab Non-Aspirin2 in 1 PACKETTABLET22
55305-126-02AeroTab Non-Aspirin25 in 1 BOXTABLET252
55305-126-04AeroTab Non-Aspirin50 in 1 BOXTABLET502
55305-126-05AeroTab Non-Aspirin125 in 1 BOXTABLET1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55305-126AEROTAB NON-ASPIRIN (ACETAMINOPHEN 500MG ES) TABLET [AERO HEALTHCARE]2Current NDC, 4 package rows20250228_faa3a4ef-3c70-06ca-e053-6394a90a512d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNfaa3a4ef-3c70-06ca-e053-6394a90a512d2
198440acetaminophen 500 MG Oral TabletSCDfaa3a4ef-3c70-06ca-e053-6394a90a512d2
198440APAP 500 MG Oral TabletSYfaa3a4ef-3c70-06ca-e053-6394a90a512d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55305-126-01553050126012 in 1 PACKETHistorical
55305-126-025530501260225 PACKET in 1 BOX (55305-126-02) / 2 TABLET in 1 PACKET (55305-126-01) 25 packet2017-10-31NoNoCurrent
55305-126-045530501260450 PACKET in 1 BOX (55305-126-04) / 2 TABLET in 1 PACKET (55305-126-01) 50 packet2017-10-31NoNoCurrent
55305-126-0555305012605125 PACKET in 1 BOX (55305-126-05) / 2 TABLET in 1 PACKET (55305-126-01) 125 packet2017-10-31NoNoCurrent