FDA.reportPublic FDA data

Stomach Relief

Product NDC
17856-1286
11-digit product format
178561286
Labeler code
17856
Product ID
17856-1286_34f36bfa-3ffc-825c-e063-6394a90a45b9
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-29
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-1286-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-1286-21332a3947898…d4bfe170f9cd…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-1286-286f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-1286-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-1286-2bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-1286-1bd6a592717d7…303034d00443…

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
Stomach Relief
Brand name suffix
Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

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
5c02d0ba-91e4-4bd2-ac66-6905323653b2Available on FDA.report

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
17856-1286-12024-04-19Drug Facts
17856-1286-22024-04-19Drug Facts
17856-1286-12024-01-30Drug Facts
17856-1286-22024-01-30Drug Facts
17856-1286-12022-05-19Drug Facts
17856-1286-22022-05-19Drug Facts
17856-1286-12022-01-28Drug Facts
17856-1286-22022-01-28Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1286-1Stomach ReliefRegular Strength50 in 1 BOX, UNIT-DOSELIQUID505
17856-1286-2Stomach ReliefRegular Strength50 in 1 BOX, UNIT-DOSELIQUID505
17856-1286-3Stomach ReliefRegular Strength15 mL in 1 CUP, UNIT-DOSELIQUID155
17856-1286-4Stomach ReliefRegular Strength30 mL in 1 CUP, UNIT-DOSELIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1286STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORP.]5Current NDC, Legacy NDC, 4 package rows20250514_5c02d0ba-91e4-4bd2-ac66-6905323653b2.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 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Pain Relieving Cream with Menthol 10%MENTHOL 10% CREAMONE2ZEE LIMITED LIABILITY COMPANYae09e93f-3988-4477-ae53-b2f3df9769fb2025-05-05WarningsExact identifier
application number: M
Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.edf07b7f-46fb-4915-b2ea-83d852617f602025-04-10WarningsExact identifier
application number: M
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb6559fb9-2dea-49c0-a274-3e77741a0ffd2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLdeecdb72-4cdb-4d6f-972f-a425a91afa5a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLdffdfa2c-a52e-4606-9b07-c8993e499f092025-03-23WarningsExact identifier
application number: M
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRL1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH KIDSDEXTROMETHORPHAN HBR-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb0fd2f2f-5cc4-4813-8f99-c78fbe8986562025-03-13WarningsExact identifier
application number: M
Menthol Pain Relief Gel PatchMENTHOL PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANYeab185d6-2a54-489d-8114-fe8088624ba42025-03-04WarningsExact identifier
application number: M
Lidocaine 4% Pain Relief Gel PatchLIDOCAINE 4% PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANY8e5a4ef4-b928-44b3-842c-92f1531af75b2025-03-03WarningsExact identifier
application number: M
gas reliefSIMETHICONEStrategic Sourcing Services LLC23005295-c5f2-4a76-8431-4a9b8d817d4d2025-01-03WarningsExact identifier
application number: M
Foster and Thrive infants Gas reliefSIMETHICONEStrategic Sourcing Services LLC824c9dff-0a26-4710-a25b-39df631d6fa62024-12-13WarningsExact identifier
application number: M
BRONCOCHEM COLD AND FLU TEAACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLb7d3f54e-59ef-4b85-a88d-b053058dc1f62024-12-12WarningsExact identifier
application number: M
HYSAN PAIN RELIEVERMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDbad73234-c204-40a8-8176-45c75ae500c82024-10-07WarningsExact identifier
application number: M
HYSAN ANALGESICMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTD99a13b0a-1d77-479e-ba99-2cfa638de3392024-10-04WarningsExact identifier
application number: M
HYSAN HUO LU MEDICATEDMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDfe9eeaff-fcbf-4287-9f17-bcf1822bf35b2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO MEDICATEDMETHYL SALICYLATEHYSAN PHARMACEUTICAL CO LTDb84c4d33-5a77-46e0-b04e-32f73967bd1c2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO HUO LUMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDcd2288c4-9909-43c1-91da-b15545b097882024-10-04WarningsExact identifier
application number: M
CLARINS - ROLL-ON DEODORANT Aluminum Chlorohydrate - Antiperspirant, Long-lasting Alcohol-freeALUMINUM CHLOROHYDRATELaboratoires Clarins412116a1-f9af-4c03-85e0-aad5738dd7972024-08-05WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRL1a3ed214-e09b-4266-b68b-39e7c3127d262024-04-22WarningsExact identifier
application number: M
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions835c3c23-fc3c-404e-8e87-5a01761267302024-02-28WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 1.75 % Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-1286-11785612860150 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1286-1) / 15 mL in 1 CUP, UNIT-DOSE (17856-1286-3) 2024-04-180000-00-00NoNoCurrent
17856-1286-21785612860250 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1286-2) / 30 mL in 1 CUP, UNIT-DOSE (17856-1286-4) 2024-04-180000-00-00NoNoCurrent
17856-1286-31785612860315 mL in 1 CUP, UNIT-DOSE15 mlHistorical
17856-1286-41785612860430 mL in 1 CUP, UNIT-DOSE30 mlHistorical