FDA.reportPublic FDA data

Equaline Stomach Relief

Product NDC
41163-535
11-digit product format
411630535
Labeler code
41163
Product ID
41163-535_f2ef3cc3-4628-4e55-ad55-4887b203c5b2
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
UNITED NATURAL FOODS, INC. DBA UNFI
Application
part335
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-13
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Equaline Stomach Relief
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
f2ef3cc3-4628-4e55-ad55-4887b203c5b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-535-04Equaline Stomach Relief236 mL in 1 BOTTLELIQUID2361

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-535-04ML - Milliliter41163-535ef5f765a-9534-448e-a9e2-d4d94973ac7212024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-535EQUALINE STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [UNITED NATURAL FOODS, INC. DBA UNFI]1Current NDC, 1 package rows20240514_f2ef3cc3-4628-4e55-ad55-4887b203c5b2.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFIf2ef3cc3-4628-4e55-ad55-4887b203c5b22024-05-13WarningsExact identifier
ndc (product): 41163-535

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSNf2ef3cc3-4628-4e55-ad55-4887b203c5b21
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCDf2ef3cc3-4628-4e55-ad55-4887b203c5b21
308762bismuth subsalicylate 1.75 % Oral SuspensionSYf2ef3cc3-4628-4e55-ad55-4887b203c5b21
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSYf2ef3cc3-4628-4e55-ad55-4887b203c5b21
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSYf2ef3cc3-4628-4e55-ad55-4887b203c5b21
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSYf2ef3cc3-4628-4e55-ad55-4887b203c5b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41163-535-0441163053504236 mL in 1 BOTTLE (41163-535-04) 236 ml2024-05-13NoNoCurrent