FDA.reportPublic FDA data

Cold and Head Congestion Relief

Product NDC
67091-212
11-digit product format
670910212
Labeler code
67091
Product ID
67091-212_2d9c9b1f-1049-497e-9d6e-ab7e8777bf46
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WinCo Foods, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-08-06
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
Cold and Head Congestion Relief
Brand name suffix
Severe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1243679Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a39778ba-1f63-4495-8e9b-44b0bdd7f71aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-212-24Cold and Head Congestion ReliefSevere12 in 1 BLISTER PACKTABLET, FILM COATED1214
67091-212-24Cold and Head Congestion ReliefSevere2 in 1 CARTONTABLET, FILM COATED214

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
GUAIFENESINACTIVE MOIETY495W7451VQCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-212COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WINCO FOODS, LLC]13Current NDC, Legacy NDC, 2 package rows20240323_a39778ba-1f63-4495-8e9b-44b0bdd7f71a.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 25 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC9aca1a68-893c-4770-8a48-d5d6780582532026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCd26b5143-aa07-4114-a6ba-4f503aadd46f2026-05-27WarningsExact identifier
application number: M012
Goodmeds Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.37533188-8c91-428b-a796-c5afd9e4959f2026-05-27WarningsExact identifier
application number: M012
Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC8252cdec-b668-4450-b045-e093479ab5422026-05-27WarningsExact identifier
application number: M012
Delsym Nighttime CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC27f9d2db-38ce-41d2-8f1a-0eb1716002742026-05-27WarningsExact identifier
application number: M012
Delsym Cough Plus Sore ThroatACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCb37b786e-0cce-419d-94ed-3b64a1eb12012026-05-27WarningsExact identifier
application number: M012
Delsym CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCa43d59f9-3a6c-4a7c-b98d-b86d6035f7162026-05-27WarningsExact identifier
application number: M012
Cold and Flu Relief Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation5700ef26-ffa6-480a-bf36-bd5111799e9b2026-05-27WarningsExact identifier
application number: M012
Air PowerGUAIFENESINSchwabe North America, Inc5cdefc7a-6242-4681-88a3-04422a1d48d32026-05-27WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALMART INC.adb658c8-db8d-4db6-80c8-e0f2de88a2de2026-05-27WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacyc71427d4-707f-411f-8bd4-133517a9992b2026-05-26WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLCVS PHARMACY, INC643e929d-9e62-4260-91ee-e88a184dd7cd2026-05-26WarningsExact identifier
application number: M012
TopCare Day Time Nite Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLCc00ff684-acaf-4fbe-bc74-7e48751b927d2026-05-26WarningsExact identifier
application number: M012
Goodmeds Non-Drowsy Nasal Decongestant PEPHENYLEPHRINECabinet Health P.B.C.4e75da23-35f2-431c-92cb-c2c4cb3f09f12026-05-26WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS Pharmacy13492631-d5de-4562-a201-664f7d3591de2026-05-26WarningsExact identifier
application number: M012
Sinufrin DecongestantNASAL CONGESTION RELIEFNeilMed Pharmaceuticals Inc52a2e5f9-e0a2-02f7-e063-6294a90a3ae92026-05-25WarningsExact identifier
application number: M012
Cough Suppressant AdultDEXTROMETHORPHAN HYDROBROMIDERugby Laboratories47b713bd-4c1e-f44a-e063-6294a90a63d32026-05-25WarningsExact identifier
application number: M012
ClorReliefCHLORPHENIRAMINE MALEATEFERRER MEDICAL INNOVATIONS LLCdb729011-f72f-5911-e053-2a95a90a68bf2026-05-22WarningsExact identifier
application number: M012
Childrens Dye Free Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporation74ff4f0d-7952-4b74-b1b2-5a2beab91f7c2026-05-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNa39778ba-1f63-4495-8e9b-44b0bdd7f71a14
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDa39778ba-1f63-4495-8e9b-44b0bdd7f71a14
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYa39778ba-1f63-4495-8e9b-44b0bdd7f71a14
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYa39778ba-1f63-4495-8e9b-44b0bdd7f71a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-212-24670910212242 BLISTER PACK in 1 CARTON (67091-212-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-08-060000-00-00NoNoCurrent