FDA.reportPublic FDA data

Nasal Decongestant

Product NDC
21130-112
11-digit product format
211300112
Labeler code
21130
Product ID
21130-112_b6ce85aa-3b57-4635-bc2b-8b9e8b1d6984
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Better Living Brands, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1981-08-25
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Nasal Decongestant
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049160Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9fe63ca6-3863-4175-9aec-ecd6ebbdb249Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-112-08Nasal DecongestantMaximum Strength1 in 1 CARTONTABLET, FILM COATED115
21130-112-08Nasal DecongestantMaximum Strength24 in 1 BLISTER PACKTABLET, FILM COATED2415

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IENASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2
TRIACETININACTIVE INGREDIENTXHX3C3X673NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-112NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]14Current NDC, Legacy NDC, 2 package rows20250110_9fe63ca6-3863-4175-9aec-ecd6ebbdb249.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 160 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Effervescent Cold Relief OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEFamily Dollar Services, Inc.4e13511b-fbb5-2523-e054-00144ff88e882024-07-03WarningsExact identifier
application number: M012
Nighttime Cherry Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATETARGET CORPORATION1c3f6cbf-a00d-45b9-e063-6394a90a797c2024-07-02WarningsExact identifier
application number: M012
Cold Terminator Cold ReliefPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWildman Business Groupe8538d9c-f9ba-40b1-b60f-f57921f39b642024-07-01WarningsExact identifier
application number: M012
Nighttime Severe Honey Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION1c02e465-8750-a088-e063-6394a90a8efb2024-06-29WarningsExact identifier
application number: M012
ACTIDOM DMXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLC0166322e-7dbb-4658-a5c5-1d0525bb76552024-06-28WarningsExact identifier
application number: M012
ACTINEL DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLACTIPHARMA, LLC16660d82-524b-42ca-8581-48237caa13b22024-06-28WarningsExact identifier
application number: M012
PurgenLabs AcetaminophenACTAMINOPHENAdvanced Rx LLC915c4608-af1b-4119-8291-4ce9fd701d762024-06-28WarningsExact identifier
application number: M012
Daytime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCLTARGET CORPORATION1bc90b2f-612c-e977-e063-6294a90a40b42024-06-26WarningsExact identifier
application number: M012
Halls MentholyptusMENTHOLMondelez Global LLCf5292c5b-5608-4e13-afc2-4f3d7133da882024-06-25WarningsExact identifier
application number: M012
Halls StrawberryMENTHOLMondelez Global LLC75638f29-7f2a-46b0-b8a0-e87bc7d6eba12024-06-25WarningsExact identifier
application number: M012
Good Sense Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEA-S Medication Solutions5396a9cf-16eb-4628-9432-f49c67ffe2ce2024-06-25WarningsExact identifier
application number: M012
Nighttime Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETARGET CORPORATION130ca5f1-2951-ec6f-e063-6394a90a754f2024-06-24WarningsExact identifier
application number: M012
Daytime and Nighttime Severe Honey Cold and FluDAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATETARGET CORPORATION08fd1513-30ab-15da-e063-6394a90ab57d2024-06-21WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe cold and fluDAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION0c0caa59-0637-bc33-e063-6294a90ae2442024-06-21WarningsExact identifier
application number: M012
Halls StrawberryMENTHOLMondelez Global LLCde401eb4-3282-4298-8a51-15d2682534642024-06-21WarningsExact identifier
application number: M012
Cough and Chest Congestion DM Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINWalgreense4515d0e-c12b-40cd-8218-6d91476cfebd2024-06-21WarningsExact identifier
application number: M012
SUDOGESTPSEUDOEPHEDRINE HCLA-S Medication Solutions1811199f-bf88-475f-8f94-b372db4bead32024-06-20WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Soft ChewsACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC91dbb541-6a86-4803-a1fe-1bf61b457c342024-06-19WarningsExact identifier
application number: M012
Tukol Max Action Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAaedce1f9-4902-4c51-92e0-6056196394c22024-06-14WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIdbc71f58-0704-4d2b-aed1-0dc01f9800062024-06-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN9fe63ca6-3863-4175-9aec-ecd6ebbdb24915
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD9fe63ca6-3863-4175-9aec-ecd6ebbdb24915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-112-08211300112081 BLISTER PACK in 1 CARTON (21130-112-08) / 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1981-08-250000-00-00NoNoCurrent