FDA.reportPublic FDA data

CVS Health Extra Strength Antacid and Pain Reliever

Product NDC
69842-542
11-digit product format
698420542
Labeler code
69842
Product ID
69842-542_26e18714-2e23-8d8d-e063-6394a90ab3ac
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin, Anhydrous Citric Acid, Sodium Bicarbonate
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
CVS Pharmacy
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-30
Marketing end
2026-12-31
Substance
ANHYDROUS CITRIC ACID; SODIUM BICARBONATE; ASPIRIN
Active strength
1000; 1985; 500 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
CVS Health Extra Strength Antacid and Pain Reliever

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANHYDROUS CITRIC ACID1000 mg/1
SODIUM BICARBONATE1985 mg/1
ASPIRIN500 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
8MDF5V39QOInternal UNII lookup
R16CO5Y76EInternal 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
afe9e755-18ba-305f-e053-2995a90aa8d0Available 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
69842-542-36CVS Health Extra Strength Antacid and Pain Reliever18 in 1 CARTONTABLET, EFFERVESCENT183
69842-542-36CVS Health Extra Strength Antacid and Pain Reliever2 in 1 POUCHTABLET, EFFERVESCENT23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-542CVS HEALTH EXTRA STRENGTH ANTACID AND PAIN RELIEVER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [CVS PHARMACY]3Current NDC, Legacy NDC, 2 package rows20241116_afe9e755-18ba-305f-e053-2995a90aa8d0.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 64 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain and FeverACETAMINOPHENH E B86a072a9-c3b8-47f7-8598-d66e3d30e7622024-08-21WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENKroger Companyd965eba0-b268-41b2-8e02-5f6d769a44d72024-08-18WarningsExact identifier
application number: M013
equate pain and fever childrensACETAMINOPHENWal-Mart Stores Incea68d735-c677-4280-a3a3-ae3eb5ff74622024-08-17WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENCVS Pharmacyfac408f0-ebb6-4c72-88ee-2ba85867859c2024-08-16WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENBryant Ranch Prepack3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad242024-08-14WarningsExact identifier
application number: M013
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma6ec12573-03d6-40c1-9945-d345b401e0622024-08-12WarningsExact identifier
application number: M013
CareOne Infants AcetaminophenACETAMINOPHENAmerican Sales Companyeacee273-abd7-4ea4-bcaa-7f74abcc9feb2024-08-07WarningsExact identifier
application number: M013
infants pain and feverACETAMINOPHENKroger Company7dbe284a-c0d5-4ac4-8445-611610f3c0fb2024-08-02WarningsExact identifier
application number: M013
Dollar General Effervescent Pain RelieverASPIRINDolgencorp, Inc1deab362-a325-3a00-e063-6294a90a9acd2024-08-01WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA STORE INC.1cd6a3e6-1376-0b7b-e063-6394a90af3d12024-07-30WarningsExact identifier
application number: M013
pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLPublix Super Markets Inc42d271b7-b45f-4497-8de2-4e05b4bebfa92024-07-17WarningsExact identifier
application number: M013
basic care acetaminophen pmACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC64a0084a-e29e-4c1a-8704-13a3e1238f762024-07-17WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWalmart Inc.152c013a-c81c-f8f9-e063-6294a90a9f232024-07-15WarningsExact identifier
application number: M013
Diphenhydramine HCLDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.5411544e-3c2d-4e42-e054-00144ff8d46c2024-07-10WarningsExact identifier
application number: M013
good sense pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL. Perrigo Companyb97c51ad-4953-4491-9ceb-395550eb52962024-07-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreens065e6f1b-f68c-491a-a157-84961a07e3d92024-07-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreens3b7b6725-2996-44d3-89a3-032384e7e2ce2024-07-10WarningsExact identifier
application number: M013
equate pain and fever infantsACETAMINOPHENWal-Mart Stores Inc8a152c8d-8ae0-4201-8bb9-7b22c35774152024-07-10WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWinCo Foods, LLC3c57498c-86b0-4ba3-881e-c742a2e8ece52024-07-09WarningsExact 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 TabletPSNafe9e755-18ba-305f-e053-2995a90aa8d03
1536833aspirin 500 MG / citric acid 1000 MG / sodium bicarbonate 1985 MG Effervescent Oral TabletSCDafe9e755-18ba-305f-e053-2995a90aa8d03
1536833ASA 500 MG / Citric Acid 1000 MG / NaHCO3 1985 MG Effervescent Oral TabletSYafe9e755-18ba-305f-e053-2995a90aa8d03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-542-366984205423618 POUCH in 1 CARTON (69842-542-36) / 2 TABLET, EFFERVESCENT in 1 POUCH18 pouch2020-12-302026-12-31NoNoCurrent