FDA.reportPublic FDA data

Alka-Seltzer Heartburn and Pain

Product NDC
0280-0160
11-digit product format
002800160
Labeler code
0280
Product ID
0280-0160_2928e140-c867-5bf5-e063-6394a90ab024
Type
HUMAN OTC DRUG
Nonproprietary name
ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-03
Substance
ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE
Active strength
1000; 325; 1916 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
Alka-Seltzer Heartburn and Pain
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANHYDROUS CITRIC ACID1000 mg/1
ASPIRIN325 mg/1
SODIUM BICARBONATE1916 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XF417D3PSLInternal UNII lookup
R16CO5Y76EInternal 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
1536675Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2928e140-c868-5bf5-e063-6394a90ab024Available 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
0280-0160-01Alka-Seltzer Heartburn and Pain2 in 1 POUCHTABLET, EFFERVESCENT21
0280-0160-01Alka-Seltzer Heartburn and Pain58 in 1 CARTONTABLET, EFFERVESCENT581
0280-0160-02Alka-Seltzer Heartburn and Pain6 in 1 CARTONTABLET, EFFERVESCENT61
0280-0160-02Alka-Seltzer Heartburn and Pain2 in 1 POUCHTABLET, EFFERVESCENT21
0280-0160-03Alka-Seltzer Heartburn and Pain12 in 1 CARTONTABLET, EFFERVESCENT121
0280-0160-03Alka-Seltzer Heartburn and Pain2 in 1 POUCHTABLET, EFFERVESCENT21
0280-0160-04Alka-Seltzer Heartburn and Pain18 in 1 CARTONTABLET, EFFERVESCENT181
0280-0160-04Alka-Seltzer Heartburn and Pain2 in 1 POUCHTABLET, EFFERVESCENT21
0280-0160-05Alka-Seltzer Heartburn and Pain36 in 1 CARTONTABLET, EFFERVESCENT361
0280-0160-05Alka-Seltzer Heartburn and Pain2 in 1 POUCHTABLET, EFFERVESCENT21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0160ALKA-SELTZER HEARTBURN AND PAIN (ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.]1Current NDC, 10 package rows20250204_2928e140-c868-5bf5-e063-6394a90ab024.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 36 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TEXACLEAR PAIN RELIEVERCAFFEINE, CHOLINE SALICYLATEGM Pharmaceuticals, INC065bd10c-3bcf-486f-a49c-40544127007f2025-10-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENASCLEMED USA INC.db8e6702-88ac-4db2-9dd8-7d0ed997c2b52025-10-14WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyfa33f6ef-522b-4630-9716-92371d9cd24a2025-10-14WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENRite Aid Corporationa8bb4f45-7a1a-4bf7-92ca-3afd508032f32025-10-09WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENHealth Pharma USA LLCb15a7dcb-f143-4aea-8850-d0aacbf709b62025-10-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.3f96aeb1-a533-4d36-9a1f-62fc094b67542025-10-08WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreensf2eb9575-d527-44c7-aa5e-efabfd9a02782025-10-07WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INCbbc704e5-79f6-4c72-846b-cc30c5c43cb42025-10-07WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRINCHAIN DRUG MARKETING ASSOCIATION INCf1ce15a3-9824-4eb5-910a-39078165f3852025-10-07WarningsExact identifier
application number: M013
BupropiDexDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.90cc9bcd-7891-4324-a1f4-f6df7a0457e02025-10-06WarningsExact identifier
application number: M013
DextabsDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.71b567df-844a-4563-b85a-f4592233f37d2025-10-06WarningsExact identifier
application number: M013
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINERising Pharma Holdings, Inc.50f72713-50f5-4bab-9e96-b9fa73c9df1f2025-10-06WarningsExact identifier
application number: M013
OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mLACETAMINOPHEN 160 MG / 5 MLMEDWISE LIFESCIENCES INC.40507559-aee4-a603-e063-6394a90afc4f2025-10-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.004c39cd-b4f4-1cae-e063-6394a90a06972025-10-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENFamily Dollar (FAMILY WELLNESS)43573e35-6776-446e-aa28-75c8edc5b98d2025-10-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENFamily Dollar (FAMILY WELLNESS)f8e5fab4-1212-4c60-a160-9b782f76a1982025-10-03WarningsExact identifier
application number: M013
CVS AcetaminophenACETAMINOPHENCVS Pharmacy3d71a0aa-5e03-0bdc-e063-6294a90a66342025-10-02WarningsExact identifier
application number: M013
Chewable AspirinASPIRINChain Drug Marketing Association, Inc.cc865351-34e8-4e8e-b8bf-23336c45bc612025-10-02WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENBryant Ranch Prepack8e40f8f1-03c5-444b-8b5e-4532c3146e472025-10-02WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINProficient Rx LP9f9355f7-024a-4adc-bb4c-2d9c0dd0cb772025-10-01WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletPSN2928e140-c868-5bf5-e063-6394a90ab0241
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD2928e140-c868-5bf5-e063-6394a90ab0241
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY2928e140-c868-5bf5-e063-6394a90ab0241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0280-0160-010028001600158 POUCH in 1 CARTON (0280-0160-01) / 2 TABLET, EFFERVESCENT in 1 POUCH58 pouch2025-02-03NoNoCurrent
0280-0160-02002800160026 POUCH in 1 CARTON (0280-0160-02) / 2 TABLET, EFFERVESCENT in 1 POUCH6 pouch2025-02-03NoNoCurrent
0280-0160-030028001600312 POUCH in 1 CARTON (0280-0160-03) / 2 TABLET, EFFERVESCENT in 1 POUCH12 pouch2025-02-03NoNoCurrent
0280-0160-040028001600418 POUCH in 1 CARTON (0280-0160-04) / 2 TABLET, EFFERVESCENT in 1 POUCH18 pouch2025-02-03NoNoCurrent
0280-0160-050028001600536 POUCH in 1 CARTON (0280-0160-05) / 2 TABLET, EFFERVESCENT in 1 POUCH36 pouch2025-02-03NoNoCurrent