Home NDC 76095-010 Cold Medicine
Product NDC 76095-010
11-digit product format 760950010
Labeler code 76095
Product ID 76095-010_24b2650e-08a1-0752-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 2017-08-01
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 4; 10 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 FORTE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 CHLORPHENIRAMINE MALEATE 4 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup V1Q0O9OJ9Z Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1193293 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76095-010-01 Cold MedicineXL3 FORTE 10 in 1 BLISTER PACK TABLET 10 7 76095-010-02 Cold MedicineXL3 FORTE 10 in 1 BLISTER PACK TABLET 10 7 76095-010-04 Cold MedicineXL3 FORTE 4 in 1 PACKET TABLET 4 7 76095-010-10 Cold MedicineXL3 FORTE 1 in 1 BOX TABLET 1 7 76095-010-20 Cold MedicineXL3 FORTE 2 in 1 BOX TABLET 2 7 76095-010-50 Cold MedicineXL3 FORTE 50 in 1 BOX TABLET 50 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76095-010 COLD MEDICINE XL3 FORTE (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [MIDWAY IMPORTING INC.] 7 Current NDC, Legacy NDC, 6 package rows 20241027_58252f15-485c-3061-e053-2a91aa0a2320.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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76095-010-01 76095001001 10 in 1 BLISTER PACK Historical 76095-010-02 76095001002 10 in 1 BLISTER PACK Historical 76095-010-04 76095001004 4 in 1 PACKET Historical 76095-010-10 76095001010 1 BLISTER PACK in 1 BOX (76095-010-10) / 10 TABLET in 1 BLISTER PACK (76095-010-01) 1 blister pack 2018-02-01 0000-00-00 No No Current 76095-010-20 76095001020 2 BLISTER PACK in 1 BOX (76095-010-20) / 10 TABLET in 1 BLISTER PACK (76095-010-02) 2 blister pack 2018-02-01 0000-00-00 No No Current 76095-010-50 76095001050 50 PACKET in 1 BOX (76095-010-50) / 4 TABLET in 1 PACKET (76095-010-04) 50 packet 2017-08-01 0000-00-00 No No Current