FDA.reportPublic FDA data

Cold Medicine

Product NDC
76095-011
11-digit product format
760950011
Labeler code
76095
Product ID
76095-011_24b2650e-08a2-0752-e063-6394a90a4b90
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Midway Importing, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-27
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 2; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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
Cold Medicine
Brand name suffix
XL3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
CHLORPHENIRAMINE MALEATE2 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
V1Q0O9OJ9ZInternal 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
1046781Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e41b9beb-e274-5c02-e053-2995a90ad0f8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76095-011-20Cold MedicineXL32 in 1 BOXTABLET22
76095-011-20Cold MedicineXL310 in 1 BLISTER PACKTABLET102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76095-011COLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [MIDWAY IMPORTING, INC.]2Current NDC, Legacy NDC, 2 package rows20241027_e41b9beb-e274-5c02-e053-2995a90ad0f8.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 71 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Honey Lemon cough dropsMENTHOLWalmart Stores Inc.317bbd33-6087-3af1-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Good Sense Nasal DecongestantPSEUDOEPHEDRINE HCLL. Perrigo Company455b35b4-3969-411b-8036-887615d71e112025-12-21WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLSafeway Inc.4a4f7f82-1b6c-7082-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
Cherry Cough DropMENTHOLSafeway Inc.4a52c0c2-8659-2819-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Signature Care Cherry Cough DropsMENTHOLSafewaya733e905-af15-d3ea-e053-2a95a90aa7c32025-12-20WarningsExact identifier
application number: M012
Signature Care Honey Lemon Cough DropsMENTHOLSafewaya742449f-c76b-2b91-e053-2a95a90ae4d22025-12-20WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINETopCo60b876e7-c642-5ce8-e053-2a91aa0abd6e2025-12-20WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLTopco Associates366cc6b1-beff-29d2-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLTopCo Associates3fef2117-7311-1e66-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLTopco Associates3ff1bf05-e407-3b67-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLTopco Associates36727f0c-d6d2-28a3-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLTopco Associates36824bee-607e-7095-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Mixed Berry Sore Throat LozengesBENZOCAINETopco Associates7a00c771-9231-e877-e053-2a91aa0ac96e2025-12-20WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGNUVICARE LLCe25b440e-f389-443f-b333-c66ad17471582025-12-19WarningsExact identifier
application number: M012
Cold and Flu severeACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCLWal-Mart Stores Inc9fca25dc-f63e-487a-8b7c-84d65ea51cb52025-12-19WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.a7d2eaee-484e-43aa-8ae3-0e050219383f2025-12-19WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLPublix66d8e5f7-9766-57f3-e053-2991aa0a7e172025-12-19WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLPublix66e89fa3-ee09-1d16-e053-2a91aa0ae17c2025-12-19WarningsExact identifier
application number: M012
Poly-Vent DMDEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.739329ae-0b62-4eab-a07d-867b5d3d61e02025-12-19WarningsExact identifier
application number: M012
Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICE89494a7c-cdbf-48f1-aaa9-2e57d4388a682025-12-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSNe41b9beb-e274-5c02-e053-2995a90ad0f82
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe41b9beb-e274-5c02-e053-2995a90ad0f82
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSYe41b9beb-e274-5c02-e053-2995a90ad0f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76095-011-20760950011202 BLISTER PACK in 1 BOX (76095-011-20) / 10 TABLET in 1 BLISTER PACK2 blister pack2022-06-270000-00-00NoNoCurrent