FDA.reportPublic FDA data

Sinus and Nasal Decongestant

Product NDC
51316-121
11-digit product format
513160121
Labeler code
51316
Product ID
51316-121_c47ffb88-fff4-47e7-af13-b3ac9fb0aecc
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-24
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 Nasal Decongestant
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
51316-121-22Sinus and Nasal Decongestant24 in 1 BLISTER PACKTABLET, FILM COATED242
51316-121-22Sinus and Nasal Decongestant2 in 1 CARTONTABLET, FILM COATED22

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 159 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare childrens allergyDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC6b784cde-3152-4421-a825-dd1fc601aa7a2024-07-17WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreens4c6b6379-3a7f-4507-a792-7b69a7f3ba822024-07-17WarningsExact identifier
application number: M012
Mucus Relief Cold Flu Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens04defcf6-e20e-402b-b725-d9394a0146b12024-07-16WarningsExact identifier
application number: M012
basic care allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC7d237d37-21c7-476d-a8b7-d91ea1b472ee2024-07-16WarningsExact identifier
application number: M012
Berkley and Jensen Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEBJWCb52fc311-8853-4116-941b-8be35456abba2024-07-16WarningsExact identifier
application number: M012
Mucus Relief All In One Daytime Nighttime Cold Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCLWalgreens0b9a4438-7d13-484c-a614-2dedc24974dc2024-07-16WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HYDROCHLORIDEPublix Super Markets Inc23a98385-28cc-4fac-8c87-b3ced81065322024-07-16WarningsExact identifier
application number: M012
Walgreens Moisturizing Ultra Fine Mist with Aloe0.05% OXYMETAZOLINEWalgreens Companyaad01028-cbe0-4c10-adbc-d157bfa5af092024-07-16WarningsExact identifier
application number: M012
Basic Care severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC924bf427-b054-46af-b341-ff162946cd582024-07-15WarningsExact identifier
application number: M012
Maximum Strength Cold TabsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEJHK DBA American Safety & First Aide7d4fe9a-eb09-4266-90c9-290f61ce6ad02024-07-15WarningsExact identifier
application number: M012
ACTIDOM DACHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLC7797c22e-ffeb-4798-9fb6-aa64cf077ba72024-07-15WarningsExact identifier
application number: M012
Nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION1cf3064d-4ddd-63b9-e063-6294a90aa5472024-07-11WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLTARGET CORPORATION1ccbdb53-3f70-28da-e063-6394a90a9ae02024-07-09WarningsExact identifier
application number: M012
AXIV Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1cd2a6f1-31ad-e507-e063-6394a90aba582024-07-09WarningsExact identifier
application number: M012
Poly Hist ForteDOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.8aa0015b-8fc1-7951-e053-2a95a90a8e722024-07-09WarningsExact identifier
application number: M012
DECONEX DMXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.8aab8e5c-1633-2e5a-e053-2a95a90adcc52024-07-09WarningsExact identifier
application number: M012
Deconex IRGUAIFENESIN AND PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.4710095e-3dae-4a39-8a98-873012e1f0032024-07-09WarningsExact identifier
application number: M012
Diabetic Tussin Sore Throat and Cough CherryBENZOCAINE AND DEXTROMETHORPHAN HBRMEDTECH PRODUCTS INCe9327079-e0fc-4c95-b1d5-bc1b74870c9b2024-07-09WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporationfac859a4-e23a-4879-af6c-26368455506d2024-07-05WarningsExact identifier
application number: M012
Severe Throat DropsMENTHOL ICETarget Corporation Inc.1876b221-fa60-5269-e063-6394a90a69632024-07-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSNbca98ea2-fdd1-468e-aafe-c4b1a5183ddb2
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCDbca98ea2-fdd1-468e-aafe-c4b1a5183ddb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-121-22513160121222 BLISTER PACK in 1 CARTON (51316-121-22) / 24 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2025-09-24NoNoCurrent