FDA.reportPublic FDA data

Quality Choice Effervescent Antacid and Pain Relief - Extra Strength

Product NDC
83324-241
11-digit product format
833240241
Labeler code
83324
Product ID
83324-241_1f9631cd-87ff-fdfc-e063-6294a90acc08
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin, Anhydrous citric acid, Sodium bicarbonate
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-12
Substance
ASPIRIN; ANHYDROUS CITRIC ACID; SODIUM BICARBONATE
Active strength
500; 1000; 1985 mg/1; mg/1; mg/1
Pharmacologic classes
Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Quality Choice Effervescent Antacid and Pain Relief - Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN500 mg/1
ANHYDROUS CITRIC ACID1000 mg/1
SODIUM BICARBONATE1985 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup
XF417D3PSLInternal UNII lookup
8MDF5V39QOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1536833Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f926637-a61c-8eb7-e063-6394a90a6502Available on FDA.report

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 27 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREENS CO.d92d97a8-0ee3-1206-e053-2a95a90a72a82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSAM'S WEST INC0c8e7095-0806-4501-e063-6394a90a89aa2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREEN CO.b3763182-2428-155a-e053-2995a90ab5782025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREENSe467b78e-9f23-5563-e053-2a95a90a586e2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWalgreensfd7c3250-35d4-494a-e053-6394a90a2db52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC1ddb8a2b-3081-3eda-e063-6294a90ab82b2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCb1307d52-10e6-46e1-e053-2995a90a03b62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCc2c6d6a1-b492-506d-e053-2995a90aac232025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
application number: M013
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINNUVICARE LLC3a4aa3c7-b726-4303-8803-74196fa5637a2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
application number: M013
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company07bc6632-fabb-427d-81f3-c27c54caa6a02025-12-17WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-241-248332402412412 POUCH in 1 CARTON (83324-241-24) / 2 TABLET, EFFERVESCENT in 1 POUCH12 pouch2026-05-12NoNoCurrent