FDA.reportPublic FDA data

Alka-Seltzer Original Flavor

Product NDC
0280-0087
Requested package NDC
0280-0087-01
11-digit product format
002800087
Labeler code
0280
Product ID
0280-0087_452648e2-82a6-84f5-e063-6394a90a6df1
Type
HUMAN OTC DRUG
Nonproprietary name
Alka-Seltzer Original Flavor
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-03
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
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 Original Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2606079Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
07478020-5ba0-3b67-e054-00144ff88e88Available 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
0280-0087-01Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-01Alka-Seltzer Original Flavor6 in 1 CARTONTABLET, EFFERVESCENT610
0280-0087-02Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-02Alka-Seltzer Original Flavor18 in 1 CARTONTABLET, EFFERVESCENT1810
0280-0087-03Alka-Seltzer Original Flavor36 in 1 CARTONTABLET, EFFERVESCENT3610
0280-0087-03Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-04Alka-Seltzer Original Flavor12 in 1 CARTONTABLET, EFFERVESCENT1210
0280-0087-04Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-06Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-06Alka-Seltzer Original Flavor58 in 1 CARTONTABLET, EFFERVESCENT5810

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANHYDROUS CITRIC ACIDACTIVE INGREDIENTXF417D3PSLALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ASPIRINACTIVE MOIETYR16CO5Y76EALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37ALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0087ALKA-SELTZER ORIGINAL FLAVOR TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.]9Current NDC, Legacy NDC, 10 package rows20241208_07478020-5ba0-3b67-e054-00144ff88e88.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 76 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC03d42892-4465-4089-90a7-cd5f00c356022023-11-29WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC57bb1acc-b9a0-48cd-8e5c-33712441ce812023-11-29WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCcc0ab7a1-e535-4dc8-962f-c58949fc17372023-11-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAurohealth LLCa4ff94b9-c248-4cd3-8491-38e9555cc22e2023-11-29WarningsExact identifier
application number: M013
Aurophen Extra Strength for AdultsACETAMINOPHENAurohealth LLCd59c5f04-4bcc-4a52-a42f-e049506f00de2023-11-29WarningsExact identifier
application number: M013
Aurophen Extra Strength for AdultsACETAMINOPHENAurohealth LLCa769094b-1e91-4ca7-ba67-21aa7e3129102023-11-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAurohealth LLC30756257-f748-4a5d-b031-dd267d0f91ad2023-11-29WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENAurohealth LLC8eda893f-5266-4b7a-95b9-2e194973cf062023-11-29WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENAurohealth LLC00ec6518-b5e3-49d1-a342-139381c3bfd22023-11-29WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEFACETAMINOPHENBetter Living Brands, LLCfadb4c09-071f-56c0-e053-6294a90ae6c12023-11-28WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEBetter Living Brands, LLCfc07d516-9ffe-9989-e053-6294a90ae1a52023-11-28WarningsExact identifier
application number: M013
NOTTS - Tension HeadacheACETAMINOPHEN, CAFFEINEVIVUNT PHARMA LLC08f2ae03-967b-ad7e-e063-6294a90a84842023-11-24WarningsExact identifier
application number: M013
Sanatos Multi Symptoms NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0a60326a-a17b-e843-e063-6394a90ac2112023-11-22WarningsExact identifier
application number: M013
Sanatos Nighttime Multi SymptomsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0ab188f3-f7f9-d665-e063-6294a90a198a2023-11-22WarningsExact identifier
application number: M013
ASPIRINASPIRINTIME CAP LABS INCfe12519c-3e5f-4592-bd34-2d6b81b981f42023-11-22WarningsExact identifier
application number: M013
Rugby Regular Strength AcetaminophenACETAMINOPHENA-S Medication Solutions400d4a29-9e39-4e74-8272-37be5d7899242023-11-22WarningsExact identifier
application number: M013
RIGHT REMEDIES Pain Relief Extra Strength CapletACETAMINOPHENStrive Pharmaceuticals Inc.dcce28d9-8528-489e-b995-1d98e9d0e6ad2023-11-21WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2606079aspirin 325 MG Effervescent Oral TabletPSN07478020-5ba0-3b67-e054-00144ff88e8810
2606079aspirin 325 MG Effervescent Oral TabletSCD07478020-5ba0-3b67-e054-00144ff88e8810
2606079ASA 325 MG Effervescent Oral TabletSY07478020-5ba0-3b67-e054-00144ff88e8810
2606079aspirin 325 MG Effervescent Oral TabletPSNf70875ab-241c-4876-e053-6294a90a80922
2606079aspirin 325 MG Effervescent Oral TabletSCDf70875ab-241c-4876-e053-6294a90a80922
2606079ASA 325 MG Effervescent Oral TabletSYf70875ab-241c-4876-e053-6294a90a80922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0280-0087-01002800087016 POUCH in 1 CARTON (0280-0087-01) / 2 TABLET, EFFERVESCENT in 1 POUCH6 pouch2023-04-18NoNoCurrent