FDA.reportPublic FDA data

WinCo Foods Effervescent Cold Relief

Product NDC
67091-109
11-digit product format
670910109
Labeler code
67091
Product ID
67091-109_26d1b568-ad98-80d7-e063-6394a90a2cbf
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin, Chlorpheniramine Maleate, and Phenylephrine Bitartrate
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
WinCo Foods, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-02
Substance
ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE
Active strength
325; 2; 7.8 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
WinCo Foods Effervescent Cold Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1
CHLORPHENIRAMINE MALEATE2 mg/1
PHENYLEPHRINE BITARTRATE7.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup
V1Q0O9OJ9ZInternal UNII lookup
27O3Q5ML57Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1536840Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d443a030-d3d6-40e0-8fe0-329de6bc494fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-109-20WinCo Foods Effervescent Cold Relief2 in 1 POUCHTABLET, EFFERVESCENT24
67091-109-20WinCo Foods Effervescent Cold Relief10 in 1 CARTONTABLET, EFFERVESCENT104

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EWINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZWINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
PHENYLEPHRINE BITARTRATEACTIVE INGREDIENT27O3Q5ML57WINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
ASPIRINACTIVE MOIETYR16CO5Y76EWINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UWINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVWINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9WINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1WINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPWINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0WINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AWINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XWINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUWINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOWINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-109WINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]4Current NDC, Legacy NDC, 2 package rows20241115_d443a030-d3d6-40e0-8fe0-329de6bc494f.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 138 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health adult tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc81f12484-ddf7-49c6-b530-3a81d62ab40d2024-11-10WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRetail Business Services, LLC230fa1ea-ae7c-425e-8447-79a90c96ae9e2024-11-10WarningsExact identifier
application number: M012
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Companycb8a1d81-b1a3-4217-b157-9e5d398f202d2024-11-09WarningsExact identifier
application number: M012
PhysiciansCare Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEAcme United Corporation5e31b1ff-291f-7b8c-e053-2a91aa0aedbc2024-11-09WarningsExact identifier
application number: M012
DurafluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.55fffc1d-8449-4c28-a391-c6f60dd856222024-11-09WarningsExact identifier
application number: M012
Poly-Vent IRGUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.ce0d8c45-446a-4df4-a36b-5000ba69d30d2024-11-09WarningsExact identifier
application number: M012
basic care tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC306d5914-03ed-410a-9345-c54ba604e9912024-11-09WarningsExact identifier
application number: M012
care one nasal originalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companya0c35e06-c9e9-438e-8224-d4760b6e2aff2024-11-09WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company34174507-cf2e-4ed4-85ec-f915d4b910df2024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl ChewablesDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCb08f71d8-a06c-41ba-8ed1-fbc41dbc19192024-11-08WarningsExact identifier
application number: M012
SUDAFED PE SINUS CONGESTIONDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCa38fdfb8-db89-487f-9b68-aa9152b91f5f2024-11-08WarningsExact identifier
application number: M012
SUDAFED Sinus CongestionPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCc05d7e27-6821-468f-b27d-9c0b02a07b0f2024-11-08WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC2884d2dc-2d4a-4ca6-ab73-688a80b428eb2024-11-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold plus Flu Multi-Action Day/NightACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATEKenvue Brands LLC712ba011-79aa-469b-9f0f-04a0b4b705bd2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8538c291-9ce9-4866-b268-f4cbdb52f5bd2024-11-08WarningsExact identifier
application number: M012
Childrens Sudafed Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC52e9307b-ad38-4f65-bb2f-4fa262e820102024-11-08WarningsExact identifier
application number: M012
Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC685b51d3-cc25-47b2-ac8a-368924f431372024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC60183922-bfd3-4377-884a-51b2f0a4c93a2024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus CongestionPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ca08917-1a75-4365-8520-c083e6a4225a2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Head Congestion Plus MucusACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCf0739186-41b9-4761-adf7-08101b30a18e2024-11-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536840aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletPSNd443a030-d3d6-40e0-8fe0-329de6bc494f4
1536840aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSCDd443a030-d3d6-40e0-8fe0-329de6bc494f4
1536840ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSYd443a030-d3d6-40e0-8fe0-329de6bc494f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-109-206709101092010 POUCH in 1 CARTON (67091-109-20) / 2 TABLET, EFFERVESCENT in 1 POUCH10 pouch2014-07-020000-00-00NoNoCurrent