FDA.reportPublic FDA data

Cold plus Head Congestion

Product NDC
36800-514
11-digit product format
368000514
Labeler code
36800
Product ID
36800-514_286004ce-751c-a742-e063-6394a90acd0c
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-08
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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

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 plus Head Congestion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 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
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
1094538Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec7e5e2e-23c5-32ae-e053-2995a90a1251Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-514-02Cold plus Head Congestion2 in 1 CARTONTABLET, COATED23
36800-514-02Cold plus Head Congestion12 in 1 BLISTER PACKTABLET, COATED123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-514COLD PLUS HEAD CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20241206_ec7e5e2e-23c5-32ae-e053-2995a90a1251.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 39 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Multi-Symptom SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companyb0d9d869-9f0d-4834-aa2b-1ee21fd8b67b2026-04-16WarningsExact identifier
application number: M012
Rompe Pecho MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc4f86985c-48f3-2148-e063-6394a90ae2f12026-04-15WarningsExact identifier
application number: M012
Childrens Daytime MucusDEXTROMETHORPHAN HBRWalgreens7a55b7e1-1054-421e-847e-5e4d90d1aebb2026-04-15WarningsExact identifier
application number: M012
Childrens Nighttime MucusDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWalgreensdc69f581-27c7-4030-bb18-39685c7691a12026-04-15WarningsExact identifier
application number: M012
Pseudoephedrine HClPSEUDOEPHEDRINE HCLMajor Pharmaceuticalsda95c643-7122-4025-977f-42205080e56b2026-04-15WarningsExact identifier
application number: M012
Daytime Nighttime ChewableDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWalgreens9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c62026-04-15WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4f7090f4-89c9-c3da-e063-6294a90a47162026-04-14WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN, PHENYLEPHRINE HCLWalgreen Company2115f095-2d75-4e02-a6af-22dd693e08402026-04-14WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLidl US LLC00f89eee-0edc-40dc-9297-8645afb910042026-04-14WarningsExact identifier
application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8647c136-a323-453a-8f57-e66938bbf6392026-04-14WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5515148f-3e1d-4b03-89fa-40967d5082922026-04-14WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc70e6506-6c5b-4d3f-ab18-a690840caabc2026-04-13WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLWalgreen Company48387b95-8240-4d6e-842b-cc29cc18709c2026-04-13WarningsExact identifier
application number: M012
Sinufrin Plus No Drip DecongestantNASAL CONGESTION RELIEFNeilMed Pharmaceuticals Inc4f06c732-1f9f-bfc6-e063-6394a90a53f52026-04-13WarningsExact identifier
application number: M012
Severe Sinus CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8745d9d8-640d-4e3b-96fe-d25032c1e3ce2026-04-13WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC5a5c5f33-5b70-465d-a38b-6f518af097882026-04-13WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLPublix Super Markets Incf2263e38-f686-45ed-bf85-b47f5e1aa9822026-04-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLBETTER LIVING BRANDS, LLC46adbf94-5b93-ee64-e063-6294a90a11442026-04-11WarningsExact identifier
application number: M012
good sense night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Company0c79357a-b79d-4952-8e6d-ef3d60dde2fa2026-04-10WarningsExact identifier
application number: M012
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC88d27c25-a305-4398-9590-df10d2504b012026-04-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094538acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSNec7e5e2e-23c5-32ae-e053-2995a90a12513
1094538acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDec7e5e2e-23c5-32ae-e053-2995a90a12513
1094538APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSYec7e5e2e-23c5-32ae-e053-2995a90a12513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-514-02368000514022 BLISTER PACK in 1 CARTON (36800-514-02) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2022-12-080000-00-00NoNoCurrent