FDA.reportPublic FDA data

AeroTab Pain Reliever

Product NDC
55305-135
11-digit product format
553050135
Labeler code
55305
Product ID
55305-135_40e2b5ea-a8eb-f1c6-e063-6394a90a1e6f
Type
HUMAN OTC DRUG
Nonproprietary name
Pain Reliever
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aero Healthcare
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-10
Substance
ASPIRIN; CAFFEINE
Active strength
500; 32.5 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
AeroTab Pain Reliever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN500 mg/1
CAFFEINE32.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702316Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
40e2b5ea-a8ea-f1c6-e063-6394a90a1e6fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55305-135-01AeroTab Pain Reliever2 in 1 PACKETTABLET, FILM COATED21
55305-135-01AeroTab Pain Reliever25 in 1 BOXTABLET, FILM COATED251
55305-135-02AeroTab Pain Reliever2 in 1 PACKETTABLET, FILM COATED21
55305-135-02AeroTab Pain Reliever50 in 1 BOXTABLET, FILM COATED501
55305-135-03AeroTab Pain Reliever2 in 1 PACKETTABLET, FILM COATED21
55305-135-03AeroTab Pain Reliever125 in 1 BOXTABLET, FILM COATED1251

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 57 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health pain reliefACETAMINOPHENDolgencorp, LLC382fa2cc-1c39-4bee-b528-08b11ec945af2024-11-02WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepackf7e20527-1d4b-434c-997b-3eb8211fdaa12024-11-01WarningsExact identifier
application number: M013
Aspirin Enteric Safety CoatedASPIRINPublix Supermarkets, Inc.a661a9ed-9b31-46b1-aafb-61d1ba8a49182024-11-01WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepack614e69c7-d3cb-4d47-9603-c1c14b87544c2024-11-01WarningsExact identifier
application number: M013
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporationbaee03b8-fcfd-440e-90ea-1ee2a18516ef2024-11-01WarningsExact identifier
application number: M013
good neighbor pharmacy infants pain and feverACETAMINOPHENAmerisource Bergenbfb954b7-3a79-4bca-95e8-d39e1074b07f2024-11-01WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEVERACETAMINOPHEN, ASPIRIN AND CAFFEINEProficient Rx LPbf365bfc-35cc-47f9-a50b-ff2b38d7316b2024-11-01WarningsExact identifier
application number: M013
Infants Pain ReliefACETAMINOPHENPublix Super Markets Inc0bc33897-afc2-4d11-be6c-a26480f448bf2024-10-31WarningsExact identifier
application number: M013
equate infants pain and feverACETAMINOPHENWALMART INC.34b2512e-743b-45db-92cb-ea05e2f47b3d2024-10-31WarningsExact identifier
application number: M013
foster and thrive infants pain and feverACETAMINOPHENStrategic Sourcing Services LLC45770ad6-9bf7-41bd-a724-e5260cd31fa12024-10-31WarningsExact identifier
application number: M013
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLETLil' Drug Store Products, Inc.d20425a4-f074-4154-e053-2995a90ae9fd2024-10-30WarningsExact identifier
application number: M013
up and up infants acetaminophenACETAMINOPHENTarget Corporation31104956-04d7-41b5-82be-219ded5c02a92024-10-30WarningsExact identifier
application number: M013
Sunmark AspirinASPIRINStrategic Sourcing Services LLCa7139686-b351-47dc-a395-832429aaa5692024-10-30WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Pain ReliefACETAMINOPHENAmerisource Bergen5101125d-4819-4e4b-a0ee-a0ff8d5a0ab12024-10-30WarningsExact identifier
application number: M013
AcetaminophenPAIN RELIEVERMcKesson9d620700-5d00-475f-e053-2995a90a9a3f2024-10-28WarningsExact identifier
application number: M013
Junior Acetaminophen Ages 6-11ACETAMINOPHENChain Drug Consortiumd356bc9c-66f1-45c3-a455-98c0b8890f782024-10-28WarningsExact identifier
application number: M013
leader AcetaminophenACETAMINOPHENCardinal Health 110, LLC. dba Leader36bdcac9-eed4-40f9-a6f2-4c1e773a6b502024-10-25WarningsExact identifier
application number: M013
GOODYS PMACETAMINOPHEN AND DIPHENHYDRAMINE CITRATEMedtech Products Inc.db5d6c2b-688e-4e88-a42d-0fa2b0d8140b2024-10-25WarningsExact identifier
application number: M013
Goodys Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.16d774cc-4247-4bf8-9b5a-c338ffebda3d2024-10-25WarningsExact identifier
application number: M013
aspirinASPIRINPUBLIX SUPER MARKETS INC9e77ab7a-07e8-42aa-e053-2995a90a0d0e2024-10-24WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702316aspirin 500 MG / caffeine 32.5 MG Oral TabletPSN40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f1
702316aspirin 500 MG / caffeine 32.5 MG Oral TabletSCD40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f1
702316ASA 500 MG / Caffeine 32.5 MG Oral TabletSY40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55305-135-015530501350125 PACKET in 1 BOX (55305-135-01) / 2 TABLET, FILM COATED in 1 PACKET25 packet2025-02-10NoNoCurrent
55305-135-025530501350250 PACKET in 1 BOX (55305-135-02) / 2 TABLET, FILM COATED in 1 PACKET50 packet2025-02-10NoNoCurrent
55305-135-0355305013503125 PACKET in 1 BOX (55305-135-03) / 2 TABLET, FILM COATED in 1 PACKET125 packet2025-02-10NoNoCurrent