Alka-Seltzer Pain Relief

Product NDC
0280-8251
11-digit product format
002808251
Labeler code
0280
Product ID
0280-8251_4975f0ff-047f-7fca-e063-6294a90aef2f
Type
HUMAN OTC DRUG
Nonproprietary name
Alka-Seltzer Pain Relief
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
ASPIRIN
Active strength
325 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Pain ReliefALKA-SELTZER PAIN RELIEFBayer HealthCare LLC.4975f0ff-0480-7fca-e063-6294a90aef2f2026-01-28WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: · hives · facial swelling · asthma (wheezing) · shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ● are age 60 or older ● have had stomach ulcers or bleeding problems ● take a blood thinning (anticoagulant) or steroid drug ● take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ● have 3 or more alcoholic drinks every day while using this product ● take more or for a longer time than directed STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.

Additional Listing Data#

Finished product
Yes
Brand name base
Alka-Seltzer Pain Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui2606079

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
0280-8251-24Alka-Seltzer Pain Relief2 in 1 POUCHTABLET, EFFERVESCENT21
0280-8251-24Alka-Seltzer Pain Relief12 in 1 CARTONTABLET, EFFERVESCENT121
0280-8251-36Alka-Seltzer Pain Relief18 in 1 CARTONTABLET, EFFERVESCENT181
0280-8251-36Alka-Seltzer Pain Relief2 in 1 POUCHTABLET, EFFERVESCENT21
0280-8251-72Alka-Seltzer Pain Relief36 in 1 CARTONTABLET, EFFERVESCENT361
0280-8251-72Alka-Seltzer Pain Relief2 in 1 POUCHTABLET, EFFERVESCENT21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2606079aspirin 325 MG Effervescent Oral TabletPSN4975f0ff-0480-7fca-e063-6294a90aef2f1
2606079aspirin 325 MG Effervescent Oral TabletSCD4975f0ff-0480-7fca-e063-6294a90aef2f1
2606079ASA 325 MG Effervescent Oral TabletSY4975f0ff-0480-7fca-e063-6294a90aef2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0280-8251-240028082512412 POUCH in 1 CARTON (0280-8251-24) / 2 TABLET, EFFERVESCENT in 1 POUCH12 pouch2025-12-01NoNoCurrent
0280-8251-360028082513618 POUCH in 1 CARTON (0280-8251-36) / 2 TABLET, EFFERVESCENT in 1 POUCH18 pouch2025-12-01NoNoCurrent
0280-8251-720028082517236 POUCH in 1 CARTON (0280-8251-72) / 2 TABLET, EFFERVESCENT in 1 POUCH36 pouch2025-12-01NoNoCurrent