FDA.reportPublic FDA data

NDC 49580-0724-01 - Stomach Relief Regular Strength

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49580-0724
Requested NDC
49580-0724-01
Package NDCs from labels
49580-0724-8, 49580-0724-6, 49580-0724-1, 49580-0724-4, 49580-0724-01
Manufacturer
P & L Development, LLC
Effective date
2025-05-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Stomach Relief Regular Strength - P & L Development, LLCP & L Development, LLC2025-05-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0724-1Stomach ReliefRegular Strength473 mL in 1 BOTTLE, PLASTICLIQUID4735
49580-0724-4Stomach ReliefRegular Strength118 mL in 1 BOTTLE, PLASTICLIQUID1185
49580-0724-6Stomach ReliefRegular Strength177 mL in 1 BOTTLE, PLASTICLIQUID1775
49580-0724-8Stomach ReliefRegular Strength237 mL in 1 BOTTLE, PLASTICLIQUID2375

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0724STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]4Current NDC, Legacy NDC, 4 package rows20240127_8383945f-b3a7-4242-bfaa-acf24b66406d.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 37 of 37 · 735 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Pepto ReliefBISMUTH SUBSALICYLATEAdvance Pharmaceutical Inc.a02babe7-9255-44c7-90e1-b5ad5e59c72a2017-12-22WarningsExact identifier
unii: 62TEY51RR1
Pep TumBISMUTH SUBSALICYLATEFirst Aid Directbf966e9f-2f95-41cd-a6e5-b8eb521181d82017-12-22WarningsExact identifier
application number: M008
unii: 62TEY51RR1
Stomach ReliefBISMUTH SUBSALICYLATECVS PHARMACY, INC.65dbe287-4528-4dbd-9116-6d4812fd4fa22017-11-28WarningsExact identifier
unii: 62TEY51RR1
Stomach ReliefBISMUTH SUBSALICYLATEPuraCap Pharmaceutical LLC01a4782f-93af-4d30-8ca3-7b39c272f60e2017-11-28WarningsExact identifier
unii: 62TEY51RR1
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: 8SKN0B0MIM
unii: PDC6A3C0OX
Pepto ReliefBISMUTH SUBSALICYLATERichmond Pharmaceuticals, Inca6f383b4-47f9-4837-93e2-2ca114fb20b92017-10-30WarningsExact identifier
unii: 62TEY51RR1
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Stomach reliefBISMUTH SUBSALICYLATECVS53cf4590-a625-42f7-bd03-8401d08b64472017-08-08WarningsExact identifier
unii: 62TEY51RR1
Maximum strength Stomach ReliefBISMUTH SUBSALICYLATECVS75326a55-7cf3-411e-96a3-a6aef6c35ca52017-08-08WarningsExact identifier
rxcui: 308762
unii: 62TEY51RR1
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Bismuth ChewableBISMUTH SUBSALICYLATE 262 MGMarc Glassman, Inc.cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e2016-12-19WarningsExact identifier
application number: M008
unii: 62TEY51RR1
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: 8SKN0B0MIM
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.