FDA.reportPublic FDA data

Soothe

Product NDC
0363-7240
11-digit product format
003637240
Labeler code
0363
Product ID
0363-7240_009dd105-86e4-493a-a019-c666b20ac8cc
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Walgreens
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-29
Marketing end
2026-12-28
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
Pharmacologic classes
Bismuth [CS], Bismuth [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
Soothe

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0363-7240-082023-10-10Drug Facts
0363-7240-082023-10-10Drug Facts
0363-7240-082023-10-10Drug Facts
0363-7240-162023-10-10Drug Facts
0363-7240-162023-10-10Drug Facts
0363-7240-162023-10-10Drug Facts
0363-7240-082023-01-30Drug Facts
0363-7240-082023-01-30Drug Facts
0363-7240-082023-01-30Drug Facts
0363-7240-162023-01-30Drug Facts
0363-7240-162023-01-30Drug Facts
0363-7240-162023-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7240-08Soothe237 mL in 1 BOTTLE, PLASTICLIQUID2377
0363-7240-16Soothe473 mL in 1 BOTTLE, PLASTICLIQUID4737

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7240SOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]6Current NDC, Legacy NDC, 2 package rows20240627_394e16b8-dd7c-4c68-86ce-3623936745a7.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 10 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEP & L Development, LLC7a461b91-d11f-4cb9-be61-c7d91d2783022024-04-16WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEGobrands, Inc. (Goodnow)cd647eb7-6e03-415c-8249-89c126824d002024-04-03WarningsExact identifier
application number: M008
Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)c443b640-18b0-4b7d-a13c-0accb915a8012024-03-05WarningsExact identifier
application number: M008
Stomach Relief - Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.970b4118-2c2e-4806-8fe8-937ba06cf6e92023-12-30WarningsExact identifier
application number: M008
Stomach Relief, Maximum StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.cdd436f6-b769-49aa-9e6c-da512da9e6e32023-12-30WarningsExact identifier
application number: M008
Stomach Relief - Maximum StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.15cd9163-16d6-4332-9e26-77c05e0a26a72023-12-30WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDemoulas Super Markets Inc9a95d198-f3ba-4bc3-a6f1-e065eb7e86f02023-12-29WarningsExact identifier
application number: M008
Stomach Relief Maximum StrengthBISMUTH SUBSALICYLATEDemoulas Super Markets Incb2d55045-d4a4-4167-a20c-42932f35bab22023-12-29WarningsExact identifier
application number: M008
STOMACH RELIEFBISMUTH SUBSALICYLATEConsumer Value Products, Inc.7526a3f2-ce7c-46c8-8ddf-1bcaf313876d2023-12-29WarningsExact identifier
application number: M008
Estomaquil PolvoBISMUTH SUBSALICYLATEProMex LLCcf94c99a-c489-45ec-bb13-3e6959e377de2023-11-29WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)3c53adaa-275f-4164-b21e-285e4f03433e2023-10-05WarningsExact identifier
application number: M008
Pepto-Bismol Chewable, TRAVEL BASIXBISMUTH SUBSALICYLATELil' Drug Store Products, Inc.dd2f2205-34d1-4960-bf37-bb8d534cd0e12023-10-03WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATECDMA- QCfe3cd0ce-933b-4ad3-a34f-c057a93561582021-06-16WarningsExact identifier
application number: M008
Topcare Stomach Relief Original StrengthBISMUTH SUBSALICYLATETopCo Associates, LLCe4b1929c-0967-44ea-8552-6549aa2a464e2018-12-14WarningsExact identifier
application number: M008
BismuthBISMUTH SUBSALICYLATEAllegiant Health015ca07a-f6b5-4741-a7b0-821cf6d4e4182018-11-07WarningsExact identifier
application number: M008
GastrobizBISMUTH SUBSALICYLATEAllegiant Healthaa516512-afd7-453f-9c73-5fa930cafac32018-09-11WarningsExact identifier
application number: M008
Pep TumBISMUTH SUBSALICYLATEFirst Aid Directbf966e9f-2f95-41cd-a6e5-b8eb521181d82017-12-22WarningsExact identifier
application number: M008
Bismuth ChewableBISMUTH SUBSALICYLATE 262 MGMarc Glassman, Inc.cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e2016-12-19WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN394e16b8-dd7c-4c68-86ce-3623936745a77
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD394e16b8-dd7c-4c68-86ce-3623936745a77
308762bismuth subsalicylate 1.75 % Oral SuspensionSY394e16b8-dd7c-4c68-86ce-3623936745a77
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY394e16b8-dd7c-4c68-86ce-3623936745a77
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY394e16b8-dd7c-4c68-86ce-3623936745a77
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY394e16b8-dd7c-4c68-86ce-3623936745a77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-7240-0800363724008237 mL in 1 BOTTLE, PLASTIC (0363-7240-08) 237 ml2019-11-292026-12-28NoNoCurrent
0363-7240-1600363724016473 mL in 1 BOTTLE, PLASTIC (0363-7240-16) 473 ml2019-11-292026-12-28NoNoCurrent