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 77 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf6401b58-8cf8-4067-e053-2995a90a68fc2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1ba37b8-4558-0808-e053-2995a90a9f5e2025-12-11WarningsExact identifier
application number: M012
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

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