FDA.reportPublic FDA data

Hyoscyamine Sulfate Sublingual

Product NDC
72189-666
Requested package NDC
72189-666-30
11-digit product format
721890666
Labeler code
72189
Product ID
72189-666_4cc2a7a4-b54a-b92a-e063-6294a90a51e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate Sublingual
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Direct_Rx
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-03-11
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hyoscyamine Sulfate Sublingual
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F2R8V82B84Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046982Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4cc2a7a4-b549-b92a-e063-6294a90a51e3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-666-30Hyoscyamine Sulfate Sublingual30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-666-30EA - Each72189-666b966a492-0064-4d6d-b4fe-b0ce1ef8a2f412026-04-20

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
Hyoscyamine Sulfate SublingualHYOSCYAMINE SULFATE SUBLINGUALDirect_Rx4cc2a7a4-b549-b92a-e063-6294a90a51e32026-03-11Warnings, Adverse reactionsExact identifier
ndc (package): 72189-666-30
ndc (product): 72189-666
ndc11 (package): 72189066630

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSN4cc2a7a4-b549-b92a-e063-6294a90a51e31
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCD4cc2a7a4-b549-b92a-e063-6294a90a51e31
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSY4cc2a7a4-b549-b92a-e063-6294a90a51e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-666-307218906663030 TABLET in 1 BOTTLE (72189-666-30) 30 tablet2026-03-11NoNoCurrent