FDA.reportPublic FDA data

CVS Health Anti-Diarrheal Vanilla

Product NDC
59779-883
11-digit product format
597790883
Labeler code
59779
Product ID
59779-883_09ba06ca-e638-4428-96fc-291ad02d3425
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
CVS Pharmacy,Inc.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-11
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/15mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
CVS Health Anti-Diarrheal Vanilla
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62TEY51RR1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308762Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ce1ed357-228b-452c-9bd4-6b0d20f41c1dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-883-12CVS Health Anti-Diarrheal Vanilla355 mL in 1 BOTTLE, PLASTICSUSPENSION3559

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-883CVS HEALTH ANTI-DIARRHEAL VANILLA (BISMUTH SUBSALICYLATE) SUSPENSION [CVS PHARMACY,INC.]8Current NDC, Legacy NDC, 1 package rows20240822_ce1ed357-228b-452c-9bd4-6b0d20f41c1d.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 8 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Upset Stomach Relief-Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATE 262 MGNUVICARE LLC6697e464-00ac-41de-a7ea-d7bb24ed5e2a2025-06-25WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEP & L Development, LLC8383945f-b3a7-4242-bfaa-acf24b66406d2025-05-30WarningsExact identifier
application number: M008
5-Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION28fba615-48ca-8d96-e063-6394a90a27972025-04-12WarningsExact identifier
application number: M008
Revasol Peptic ReliefBISMUTH SUBSALICYLATERnv LLC30dc3a0a-3496-4bdf-e063-6394a90a62fd2025-03-21WarningsExact identifier
application number: M008
Pepto Bismol CHEWABLESBISMUTH SUBSALICYLATEProcter & Gamble Manufactura S de RL de CV30b6adb2-48da-875b-e063-6394a90a593b2025-03-19WarningsExact identifier
application number: M008
TopCare Bismuth Stomach ReliefBISMUTHTopCo308f4b2a-22ff-42b9-e063-6394a90acc752025-03-17WarningsExact identifier
application number: M008
Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEGuardian Drug Company25175eac-d15f-ce0d-e063-6394a90a06502025-03-10WarningsExact identifier
application number: M008
Pink Bismuth Regular StrengthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0c675e-72ce-4a22-e063-6394a90a3dff2025-02-27WarningsExact identifier
application number: M008
Pink BismuthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0ce5dd-9eb5-8568-e063-6394a90a1a292025-02-27WarningsExact identifier
application number: M008
Maximum Strength Pink BismuthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0d4508-e5a1-ba46-e063-6394a90aec2a2025-02-27WarningsExact identifier
application number: M008
Pink Bismuth OriginalBISMUTH SUBSALICYLATE 525 MGDiscount Drug Mart, Inc2e0cb7d7-4c4f-824a-e063-6394a90aa3a42025-02-27WarningsExact identifier
application number: M008
SIMETHICONESIMETHICONENuCare Pharmaceuticals,Inc.e07f6acc-1b75-d8eb-e053-2a95a90a7d9b2025-02-24WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEHarris Teeter, LLC2c51458b-869c-0283-e063-6394a90a4ff72025-02-12WarningsExact identifier
application number: M008
Max Strength Stomach ReliefBISMUTH SUBSALICYLATEHarris Teeter, LLC2c516139-0a6a-5ba6-e063-6394a90aa14a2025-02-12WarningsExact identifier
application number: M008
Bismuth SubsalicylateBISMUTH SUBSALICYLATELEADER/ Cardinal Health 110, Inc.d4af6694-910c-da17-e053-2995a90a84542025-02-11WarningsExact identifier
application number: M008
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEDOLGENCORP, INC.f2ec112f-213c-8a23-e053-2995a90a5f3f2025-02-10WarningsExact identifier
application number: M008
Maximum Strength Stomach ReliefBISMUTH SUBSALICYLATEGuardian Drug Companyaf899b52-7d8c-4485-9fb8-006dae53568a2025-02-10WarningsExact identifier
application number: M008
CVS Health Stomach Relief SOFTGELBISMUTH SUBSALICYLATECVS Pharmacy, Inc.273013b3-9f79-873d-e063-6394a90a66402025-01-24WarningsExact identifier
application number: M008
GNP Pink BismuthBISMUTH SUBSALICYLATEAmerisource Bergen9f5df648-298a-43e3-b250-8db6786fc93f2025-01-20WarningsExact identifier
application number: M008
Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATEReliable 1 Laboratories LLC2e40ffd8-1afa-43af-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSNce1ed357-228b-452c-9bd4-6b0d20f41c1d9
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCDce1ed357-228b-452c-9bd4-6b0d20f41c1d9
308762bismuth subsalicylate 1.75 % Oral SuspensionSYce1ed357-228b-452c-9bd4-6b0d20f41c1d9
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSYce1ed357-228b-452c-9bd4-6b0d20f41c1d9
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSYce1ed357-228b-452c-9bd4-6b0d20f41c1d9
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSYce1ed357-228b-452c-9bd4-6b0d20f41c1d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-883-1259779088312355 mL in 1 BOTTLE, PLASTIC (59779-883-12) 355 ml2015-08-110000-00-00NoNoCurrent