FDA.reportPublic FDA data

Sinus and Congestion

Product NDC
49035-780
11-digit product format
490350780
Labeler code
49035
Product ID
49035-780_21e620db-2738-4f7f-a769-c9280df0cb2e
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-15
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
Sinus and Congestion
Brand name suffix
Non-Drowsy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

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
49035-780-08Sinus and CongestionNon-Drowsy1 in 1 CARTONTABLET, FILM COATED17
49035-780-08Sinus and CongestionNon-Drowsy24 in 1 BLISTER PACKTABLET, FILM COATED247
49035-780-22Sinus and CongestionNon-Drowsy24 in 1 BLISTER PACKTABLET, FILM COATED247
49035-780-22Sinus and CongestionNon-Drowsy2 in 1 CARTONTABLET, FILM COATED27
49035-780-43Sinus and CongestionNon-Drowsy24 in 1 BLISTER PACKTABLET, FILM COATED247

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-780-08EA - Each49035-780791f352d-9990-40bb-9701-227b69b9fe2d12024-08-12
49035-780-22EA - Each49035-78026aecb49-84ee-457c-b86c-cb8494075bdc12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-780SINUS AND CONGESTION NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]6Current NDC, Legacy NDC, 5 package rows20240608_cbdac7ad-3904-4a85-91a9-863f6f06503d.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 175 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.eb64750f-19ac-655f-e053-2995a90a33b52023-11-02WarningsExact identifier
application number: M012
Multi-Symptom Mapap Cold FormulaACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLProficient Rx LP9bf81b26-38b4-486c-ae89-222119ce1a4f2023-11-01WarningsExact identifier
application number: M012
Guaifenesin Syrup and DextromethorphanGUAIFENESIN SYRUP AND DEXTROMETHORPHANNatco Pharma USA LLCad9026f4-f0b6-4d02-aa44-f0460eeefc0e2023-11-01WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HYDROCHLORIDENatco Pharma USA LLC54b64354-ac10-42ff-a53d-96cef933a91a2023-11-01WarningsExact identifier
application number: M012
children allergy relief dye free cherryDIPHENHYDRAMINE HCLA-S Medication Solutions5c6c1809-4c6f-4e8f-a5ae-9796e821d4002023-11-01WarningsExact identifier
application number: M012
Daytime and Nighttime Cherry Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0903b222-1a44-64aa-e063-6294a90abba02023-10-31WarningsExact identifier
application number: M012
Ephrine Nose DropsPHENYLEPHRINE HYDROCHLORIDEWalgreensb620eb9f-2caf-0942-e053-2a95a90ae48e2023-10-31WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLA-S Medication Solutions204849d1-ac4b-4dbe-8769-fcb30291f8802023-10-31WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefDAYTIME COLD AND FLU RELIEFTopCo Associates, LLCd592fbb8-d4bf-444e-982e-edf6fe97dce42023-10-31WarningsExact identifier
application number: M012
Nite Time Cold and Flu ReliefNITE TIME COLD AND FLU RELIEFTopCo Associates, LLC407dc4ae-882d-4a49-8884-ef048bb404cf2023-10-31WarningsExact identifier
application number: M012
12 Hour Original Nasal DecongestantNASAL SPRAYSheffield Pharmaceuticals LLCcea0ce76-ae75-4484-a7c2-ff1086e9d8b02023-10-30WarningsExact identifier
application number: M012
Mucosa DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMagno-Humphries, Inc.3a5533fb-1c83-4b95-9cd2-9be663d3ff5f2023-10-27WarningsExact identifier
application number: M012
Mucosa GuifenesinGUAIFENESINMagno-Humphries, Inc.9d22c208-d0ae-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
application number: M012
DG Health Cough Drops Cherry FlavorMENTHOLDollar General Corporationc7a603d8-72fb-9626-e053-2995a90a09ea2023-10-26WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEGeri-Care Pharmaceutical Corp92d90b41-0627-121e-e053-2995a90a2df12023-10-26WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol CherryMENTHOLRiclan S.A.8e471265-3594-451a-8921-f0db474abe852023-10-26WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol EucalyptusMENTHOLRiclan S.A.1141593a-f3ba-4adf-b332-f9fcb0b5a0132023-10-26WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey LemonMENTHOLRiclan S.A.f6271e85-9ca2-41d3-9bff-a13670ac5b802023-10-26WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol StrawberryMENTHOLRiclan S.A.da2bbc92-7d96-4f3e-89e2-c2a9e3e4b4572023-10-26WarningsExact identifier
application number: M012
DG Health Cough Drops Assorted FlavorsMENTHOLDollar General Corporationc731d255-40f2-3cb3-e053-2a95a90a88772023-10-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSNcbdac7ad-3904-4a85-91a9-863f6f06503d7
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCDcbdac7ad-3904-4a85-91a9-863f6f06503d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-780-08490350780081 BLISTER PACK in 1 CARTON (49035-780-08) / 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2020-07-150000-00-00NoNoCurrent
49035-780-22490350780222 BLISTER PACK in 1 CARTON (49035-780-22) / 24 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2020-07-150000-00-00NoNoCurrent
49035-780-434903507804324 TABLET, FILM COATED in 1 BLISTER PACK (49035-780-43) 2020-07-150000-00-00NoNoCurrent