FDA.reportPublic FDA data

TopCare Effervescent Antacid and Pain Relief

Product NDC
36800-421
11-digit product format
368000421
Labeler code
36800
Product ID
36800-421_26d10f9a-a58e-eddf-e063-6394a90a166b
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin, Citric Acid, Sodium Bicarbonate
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Topco Associates LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-11
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
TopCare 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
639f9d57-f26a-708a-e053-2a91aa0a6962Available 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
36800-421-68TopCare Effervescent Antacid and Pain Relief18 in 1 CARTONTABLET, EFFERVESCENT186
36800-421-68TopCare Effervescent Antacid and Pain Relief2 in 1 POUCHTABLET, EFFERVESCENT26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-421TOPCARE EFFERVESCENT ANTACID AND PAIN RELIEF (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 2 package rows20241212_639f9d57-f26a-708a-e053-2a91aa0a6962.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 30 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf8820150-feec-4062-85bb-14525ddf691f2025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANY005e299e-aa84-49d9-bbca-12236f865a272025-12-11WarningsExact identifier
application number: M013
Low Dose Chewable AspirinASPIRINVALU MERCHANDISERS COMPANY7d88f156-d361-4249-b70d-4bbcd5ba30b72025-12-11WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINVALU MERCHANDISERS COMPANYcc18e8e1-652e-44da-a9d7-e56cebda55a12025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYd4c32e70-778a-4d66-b9d0-03944a5284212025-12-11WarningsExact identifier
application number: M013
adult low dose aspirinASPIRINVALU MERCHANDISERS COMPANY6fa1c707-bd42-455b-90a3-2c2a11acc6832025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANY5a80cb17-7731-4457-acd3-64cf4accf8622025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENVALU MERCHANDISERS COMPANY02e3798f-86d9-64b4-e063-6294a90a29de2025-12-11WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYf7e87eac-59fb-4a72-b5c6-02953112be6a2025-12-11WarningsExact identifier
application number: M013
AspirinASPIRINVALU MERCHANDISERS COMPANY049ec1aa-66b3-9273-e063-6294a90a221b2025-12-11WarningsExact identifier
application number: M013
Aspirin 325ASPIRINWalgreen Companyf7a5d612-443c-4701-ad3b-8eb53c87bece2025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma355a094c-bed9-4959-8cf0-619f0e2461052025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmafac4e0c6-684f-45a1-99f2-de4de4017cc82025-12-11WarningsExact identifier
application number: M013
Pain Reliever PM extra strengthACETAMINOPHEN DIPHENHYDRAMINE HCLP & L Development, LLC90eba2e8-52c3-43f5-ba93-4a520368c7f42025-12-11WarningsExact identifier
application number: M013
Midol Complete, Travel BASIXACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATELil' Drug Store Products, Incd6d47af8-5f8c-4c8c-a8c6-aa214ec23bca2025-12-10WarningsExact identifier
application number: M013
Tylenol PM Extra Strength, CVP HEALTHACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.643371f2-e330-441e-8932-b3aec4b179d22025-12-10WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINUnited Natural Foods, Inc. dba UNFI18b79449-5c4c-41ce-9609-80f5efa0375c2025-12-09WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad34f4-4e66-f371-e063-6394a90ae76a2025-12-09WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENLIDL US LLCec543339-20ab-2cba-e053-2995a90ac7402025-12-09WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.c57c10fc-f182-4153-8974-ef359a5f5ac12025-12-09WarningsExact 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 TabletPSN639f9d57-f26a-708a-e053-2a91aa0a69626
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD639f9d57-f26a-708a-e053-2a91aa0a69626
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY639f9d57-f26a-708a-e053-2a91aa0a69626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-421-683680004216818 POUCH in 1 CARTON (36800-421-68) / 2 TABLET, EFFERVESCENT in 1 POUCH18 pouch2014-08-112026-12-31NoNoCurrent