FDA.reportPublic FDA data

DAYTIME COLD AND FLU

Product NDC
0363-0109
11-digit product format
003630109
Labeler code
0363
Product ID
0363-0109_f159051c-27e0-52a9-e053-2995a90aeb72
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HBr,GUAIFENESIN, PHENYLEPHRINE HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-23
Substance
ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 200; 10; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0109-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0109-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0109-240efc9e666f02…f202fb6c5f17…

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
DAYTIME COLD AND FLU
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
GUAIFENESIN200 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
495W7451VQInternal UNII lookup
9D2RTI9KYHInternal 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
1656815Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbf5656b-9105-871b-e053-2995a90a4941Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0109-242025-02-11C16284748780-12cef2736-7cb4-d83d-e063-dadaa90ab31f625T WALGREENS 0363-0109 DAYTIME SEVERE COLD & FLU 24 ct
0363-0109-242025-01-30C16284748780-12cef2736-7cb4-d83d-e063-dadaa90ab31f625T WALGREENS 0363-0109 DAYTIME SEVERE COLD & FLU 24 ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0109-24DAYTIME COLD AND FLUMaximum Strength2 in 1 CARTONCAPSULE, LIQUID FILLED23
0363-0109-24DAYTIME COLD AND FLUMaximum Strength12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0109DAYTIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREENS]3Current NDC, Legacy NDC, 2 package rows20250213_dbf5656b-9105-871b-e053-2995a90a4941.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 165 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLP & L Development, LLC8d27b94d-23a1-4e6c-a064-79e2580f7e2e2024-04-15WarningsExact identifier
application number: M012
Severe Cold and Cough Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLP & L Development, LLC2af496a1-6fdd-4acf-9944-8b7cdf3022752024-04-15WarningsExact identifier
application number: M012
Childrens Dye Free AllergyDIPHENHYDRAMINE HYDROCHLORIDEP & L Development, LLC1c4d09ed-4e0f-430d-b17f-6a23f996a55d2024-04-15WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC9736ad4c-8c2e-421f-b023-f91b72d2828b2024-04-10WarningsExact identifier
application number: M012
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCLHaleon US Holdings LLCb06b64c5-dbb4-4ef5-af18-3d7d4979c02f2024-04-10WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATEHarris Teeter, LLCec603195-eb36-4b5c-bc9b-c2074205b2b22024-04-09WarningsExact identifier
application number: M012
Daytime Cold and Flu Non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLC9b0648ac-0ce3-4eaa-8977-26ae864f034d2024-04-09WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLHaleon US Holdings LLCf147d82e-4429-4c7b-bd2b-e21a09f21c922024-04-09WarningsExact identifier
application number: M012
FLONASE Headache and Allergy ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLHaleon US Holdings LLC282c103c-3888-4a35-a5b1-d492ed6892c12024-04-08WarningsExact identifier
application number: M012
ROBITUSSIN COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC4908b326-e1da-44ca-8087-7e41a16c27b02024-04-08WarningsExact identifier
application number: M012
Robitussin Direct Sore Throat PainACETAMINOPHENHaleon US Holdings LLC1b512078-24c3-4b80-8f2c-d6824d367f252024-04-08WarningsExact identifier
application number: M012
Mucus Relief Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENSINH E B9ba5ca1b-2e3c-439e-8887-c26f144b88ef2024-04-08WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E B12ace982-bd47-49b0-ba1b-e0a29d42f1d62024-04-08WarningsExact identifier
application number: M012
Allergy ChildrensDIPHENHYDRAMINE HYDROCHLORIDEH E Bab28cbc4-7a6f-46e9-8616-be78e8cb24fe2024-04-08WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E Bbd19b1f2-d9d3-4dab-8181-605f769ab62f2024-04-08WarningsExact identifier
application number: M012
Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E B9f533092-060c-4379-9a77-ecfea8aa46e12024-04-08WarningsExact identifier
application number: M012
Robitussin Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC66360295-f364-479a-8b49-c12b219182792024-04-06WarningsExact identifier
application number: M012
Robitussin Peak Cold Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC8c0a2424-e8ac-d91c-b46d-a5ee29f919362024-04-06WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEHaleon US Holdings LLCe7cf7c5d-5c9a-4201-9e30-1cd6160718552024-04-06WarningsExact identifier
application number: M012
Robitussin Medi-SoothersDEXTROMETHORPHAN HYDROBROMIDE, MENTHOLHaleon US Holdings LLC4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae52024-04-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634364{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCKda2b0276-9ab0-38e6-e053-2a95a90a54d83
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSNda2b0276-9ab0-38e6-e053-2a95a90a54d83
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSNda2b0276-9ab0-38e6-e053-2a95a90a54d83
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSNda2b0276-9ab0-38e6-e053-2a95a90a54d83
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSNdbf5656b-9105-871b-e053-2995a90a49413
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDda2b0276-9ab0-38e6-e053-2a95a90a54d83
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDda2b0276-9ab0-38e6-e053-2a95a90a54d83
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDdbf5656b-9105-871b-e053-2995a90a49413
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSYda2b0276-9ab0-38e6-e053-2a95a90a54d83
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYda2b0276-9ab0-38e6-e053-2a95a90a54d83
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYda2b0276-9ab0-38e6-e053-2a95a90a54d83
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYdbf5656b-9105-871b-e053-2995a90a49413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0109-24003630109242 BLISTER PACK in 1 CARTON (0363-0109-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2022-06-230000-00-00NoNoCurrent