FDA.reportPublic FDA data

Effervescent Antacid and Pain Relief

Product NDC
37808-421
Requested package NDC
37808-421-68
11-digit product format
378080421
Labeler code
37808
Product ID
37808-421_26d11120-569a-ea43-e063-6394a90a5963
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin, Citric Acid, Sodium Bicarbonate
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
H. E. Butt Grocery Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-10
Marketing end
2026-12-31
Substance
ASPIRIN; SODIUM BICARBONATE; ANHYDROUS CITRIC ACID
Active strength
325; 1916; 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
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
Effervescent Antacid and Pain Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1
SODIUM BICARBONATE1916 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
R16CO5Y76EInternal UNII lookup
8MDF5V39QOInternal 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
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
6418cde9-607b-4ca1-e053-2991aa0a9170Available 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
37808-421-68Effervescent Antacid and Pain Relief2 in 1 POUCHTABLET, EFFERVESCENT26
37808-421-68Effervescent Antacid and Pain Relief18 in 1 CARTONTABLET, EFFERVESCENT186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-421EFFERVESCENT ANTACID AND PAIN RELIEF (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [H. E. BUTT GROCERY COMPANY]6Current NDC, Legacy NDC, 2 package rows20241212_6418cde9-607b-4ca1-e053-2991aa0a9170.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 71 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC0faa3592-4d56-4645-9a0e-066e0bdfebb62024-04-05WarningsExact identifier
application number: M013
Pain Relief Childrens Dye FreeACETAMINOPHENH E B3f9beeeb-5e27-4b81-a647-20e65f0e9fc92024-04-03WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINH E Bedb321dd-e5cb-4031-a8a8-efce9e86fe162024-04-03WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENH E Ba0c0277e-50aa-4328-8f93-ab20c6176b2b2024-04-03WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINBryant Ranch Prepackbda805ab-7f37-405d-a144-4e06ad9a29a12024-04-03WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEFamily Dollar (FAMILY WELLNESS)650cb15e-c448-4df3-b0f8-4398be05d8412024-03-27WarningsExact identifier
application number: M013
Good Sense Effervescent Pain ReliefASPIRINPerrigo Direct, Inc.103027a7-2f0e-8d8c-e063-6294a90aedc72024-03-26WarningsExact identifier
application number: M013
rugby infants acetaminophenACETAMINOPHENRugby Laboratories8aa9ac68-ca61-4163-a876-52034138c1ea2024-03-25WarningsExact identifier
application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mgACETAMINOPHENWalmart Inc08a18481-f029-f01f-e063-6294a90aac652024-03-21WarningsExact identifier
application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mgACETAMINOPHENWalmart Inc0d106fa2-2a77-deb2-e063-6394a90a2dac2024-03-21WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)872c5220-a379-4dc1-b99c-f11ebb82db352024-03-19WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)79886972-47a4-44c5-a131-1a691a3281032024-03-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)5ffcc78d-9163-4cb4-8811-ae9f0142806a2024-03-18WarningsExact identifier
application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERHF Acquisition Co LLC, DBA HealthFirst13e621dc-b2b4-98fd-e063-6394a90acc752024-03-17WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INC097a9c98-a092-400d-9600-6797b0b9a50c2024-03-15WarningsExact identifier
application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC978a9d27-6d41-42cb-a193-11314923d2ac2024-03-14WarningsExact identifier
application number: M013
Excedrin PM Triple Action CapletsACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLCb3812d27-40af-40d7-864a-dfa4ae34cb9e2024-03-14WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC691b754c-bafc-47e2-a322-cf56245c01f62024-03-14WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INCfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2024-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)2cde052d-22a4-470f-8d6a-7c17061b8ac82024-03-14WarningsExact 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 TabletPSN6418cde9-607b-4ca1-e053-2991aa0a91706
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD6418cde9-607b-4ca1-e053-2991aa0a91706
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY6418cde9-607b-4ca1-e053-2991aa0a91706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-421-683780804216818 POUCH in 1 CARTON (37808-421-68) / 2 TABLET, EFFERVESCENT in 1 POUCH18 pouch2011-08-102026-12-31NoNoCurrent