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 78 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb84f37bc-be37-4f2b-83ee-d7d1341844902025-12-11WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1b7c7fc-1068-f486-e053-2a95a90a8e8c2025-12-11WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1b9e0da-2c54-8b31-e053-2995a90a690b2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf6b3ca40-7638-477f-b800-4c28c40ff0a82025-12-11WarningsExact identifier
application number: M012
Allergy ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company0a6e3251-02e0-42c1-bdf3-51c77f88c17f2025-12-11WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLC516ab016-31f9-4829-8b94-2f968933093c2025-12-11WarningsExact identifier
application number: M012
Sinus PE CongestionDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company5b9151b7-3e40-4f37-b3e0-4c0fa0115b712025-12-10WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDiscount Drug Mart2344c048-0550-4c31-b54e-a198910c490e2025-12-10WarningsExact identifier
application number: M012
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACY, INCcf4eb4c4-68e0-4478-a81c-d3d1e66f5cc52025-12-10WarningsExact identifier
application number: M012
Tylenol Cold plus Flu Severe, Lil Drug StoreACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil Drug Store Products, Incf395c196-62d7-47ff-b38d-af37adf5980b2025-12-10WarningsExact identifier
application number: M012
Tylenol Sinus Severe, Lil Drug StoreACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil Drug Store Products, Inc88b68447-b016-4d5b-a5e3-c4ebccb14f8c2025-12-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamily Dollar Services Incd956f1b8-91f8-424b-bb6c-704c445b6f4c2025-12-10WarningsExact identifier
application number: M012
good neighbor pharmacy day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergene5c1bd96-d27d-49c1-b3b8-eee53a145ef52025-12-10WarningsExact identifier
application number: M012
NiteTime SEVERE Cold and Flu Relief SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC3ffe67bf-2c66-61e6-e063-6394a90a7f8f2025-12-10WarningsExact identifier
application number: M012
DayTime SEVERE Cold and Flu Relief SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC3ffe0f43-b92a-f947-e063-6394a90ab72c2025-12-10WarningsExact identifier
application number: M012
MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCa7285fe0-5a5b-42c4-be47-9a07a2ba75e82025-12-10WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporationf9b8dbe1-7ff9-4320-850c-6e86e98d43932025-12-09WarningsExact identifier
application number: M012
Severe NasalOXYMETAZOLINE HYDROCHLORIDE 0.05%ALAINA HEALTHCARE PRIVATE LIMITED27747a10-8d1d-41c2-80b9-45452f3b9abc2025-12-09WarningsExact identifier
application number: M012
Vaporizing RubCAMPHOR, EUCALYPTUS OIL AND MENTHOLALAINA HEALTHCARE PRIVATE LIMITED4c6a7ac0-be76-42b0-9a08-b287e70a34602025-12-09WarningsExact identifier
application number: M012
24-7 Life BY 7-ELEVEN Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTIONLil' Drug Store products, Inc.277363f4-1c00-ddb7-e063-6294a90a46772025-12-09WarningsExact 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