daytime cold and flu

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hci 325, 10, 5 mg softgels

Labeler: time cap laboratories, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name daytime cold and flu
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hci 325, 10, 5 mg softgels
Labeler time cap laboratories, inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-693
Product ID 49483-693_2dc3a685-34e1-0823-e063-6294a90ad27d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-07-06

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49483693
Hyphenated Format 49483-693

Supplemental Identifiers

RxCUI
1086997
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name daytime cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hci 325, 10, 5 mg softgels (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (49483-693-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

49483-693-48 4 BLISTER PACK in 1 CARTON (49483-693-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Daytime cold and flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2dc3a685-34e1-0823-e063-6294a90ad27d", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["fd24653e-c4fa-3c09-e053-6394a90aaa9e"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (49483-693-48)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "49483-693-48", "marketing_start_date": "20230706"}], "brand_name": "Daytime cold and flu", "product_id": "49483-693_2dc3a685-34e1-0823-e063-6294a90ad27d", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["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]"], "product_ndc": "49483-693", "generic_name": "Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI 325, 10, 5 mg softgels", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Daytime cold and flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230706", "listing_expiration_date": "20261231"}