FDA.reportPublic FDA data

Quality Choice Extra Strength Effervescent Antacid and Pain Relief

Product NDC
63868-569
11-digit product format
638680569
Labeler code
63868
Product ID
63868-569_26d1a02f-592c-5866-e063-6394a90a253e
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
2020-11-04
Substance
SODIUM BICARBONATE; ASPIRIN; ANHYDROUS CITRIC ACID
Active strength
1985; 500; 1000 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
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
Quality Choice Extra Strength Effervescent Antacid and Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8MDF5V39QOInternal UNII lookup
R16CO5Y76EInternal UNII lookup
XF417D3PSLInternal 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
9f7d0c96-a561-a8a0-e053-2995a90a250bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-569-24Quality Choice Extra Strength Effervescent Antacid and Pain Relief2 in 1 POUCHTABLET, EFFERVESCENT23
63868-569-24Quality Choice Extra Strength Effervescent Antacid and Pain Relief12 in 1 CARTONTABLET, EFFERVESCENT123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-569-24EA - Each63868-569654d4ee1-9b1d-4746-967b-d713abd2e4bc12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-569QUALITY CHOICE EXTRA STRENGTH EFFERVESCENT ANTACID AND PAIN RELIEF (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [CHAIN DRUG MARKETING ASSOCIATION]3Current NDC, Legacy NDC, 2 package rows20241115_9f7d0c96-a561-a8a0-e053-2995a90a250b.zip

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 67 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.9fdbaf5e-f88b-4d18-97df-0b2e8dddf3772024-06-13WarningsExact identifier
application number: M013
Aspirin 81 mg Low doseASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.bfb9af64-3195-44bf-bcf3-6b36b40d3cc72024-06-13WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1ac7ed71-5afe-d09c-e063-6294a90a3b882024-06-13WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.3ce5bbf2-d449-464e-abeb-5c26866d1ab52024-06-13WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.609948d6-0f20-4d0c-adc0-6ae72a4f2b7a2024-06-13WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.3f73a359-59d7-47bb-872e-914b0db719af2024-06-13WarningsExact identifier
application number: M013
topcare infants pain and feverACETAMINOPHENTopco Associates LLCf1e940ef-3cf0-4a5c-8158-156d0e5a680d2024-06-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC026bf664-d598-73de-e063-6394a90a92062024-06-12WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.7c73fc75-af9b-177c-e053-2a91aa0ada562024-06-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINTopco Associates4a6a1dbb-c813-42fd-9bb8-497aec3394662024-06-11WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.fa234639-caf8-4c52-9ffe-f1c0c057ee5b2024-06-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.bc18590d-6481-4efe-8a3b-974f7543b7542024-06-10WarningsExact identifier
application number: M013
ASPIRINASPIRINH-E-B085b35db-62e4-38db-e063-6394a90a97632024-06-07WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inccbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf2024-06-07WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.5691ac45-5732-412e-abb8-2bfaac59160e2024-06-07WarningsExact identifier
application number: M013
Cafiaspirina Rapid Headache ReliefASPIRIN, CAFFEINEBelmora LLCd890acec-6528-4fb7-8d59-6c572a3f07862024-06-07WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINETARGET Corporation611bc1ce-460a-44a3-8e2d-b28a399d9a442024-06-06WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc033a6153-2651-4703-8a94-def4618381132024-06-05WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company126ee71a-c408-415b-9a43-502337a910552024-06-05WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENA-S Medication Solutions85294a70-3233-4ba5-bc36-ee3f2964aebf2024-06-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536833aspirin 500 MG / citric acid 1000 MG / sodium bicarbonate 1985 MG Effervescent Oral TabletPSN9f7d0c96-a561-a8a0-e053-2995a90a250b3
1536833aspirin 500 MG / citric acid 1000 MG / sodium bicarbonate 1985 MG Effervescent Oral TabletSCD9f7d0c96-a561-a8a0-e053-2995a90a250b3
1536833ASA 500 MG / Citric Acid 1000 MG / NaHCO3 1985 MG Effervescent Oral TabletSY9f7d0c96-a561-a8a0-e053-2995a90a250b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-569-246386805692412 POUCH in 1 CARTON (63868-569-24) / 2 TABLET, EFFERVESCENT in 1 POUCH12 pouch2020-11-040000-00-00NoNoCurrent