Home NDC 63654-800 Cough and Cold
Product NDC 63654-800
11-digit product format 636540800
Labeler code 63654
Product ID 63654-800_24b2193a-79ff-3792-e063-6394a90ad104
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Selder, S.A. de C.V.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-11-15
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 250; 5; 2; 10 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
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 Cough and Cold
Brand name suffix XL3 Xtra
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 CHLORPHENIRAMINE MALEATE 2 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1193292 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 63654-800-06 Cough and ColdXL3 Xtra 6 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 6 6 63654-800-12 Cough and ColdXL3 Xtra 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 6 63654-800-20 Cough and ColdXL3 Xtra 20 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 20 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 POLYETHYLENE GLYCOL 1000 INACTIVE INGREDIENT U076Q6Q621 COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 POLYETHYLENE GLYCOL 600 INACTIVE INGREDIENT NL4J9F21N9 COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63654-800 COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] 6 Current NDC, Legacy NDC, 3 package rows 20241027_da5b31dd-becd-471a-9392-d0ee4b8f9539.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 98 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63654-800-06 63654080006 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-06) 2018-10-15 0000-00-00 No No Current 63654-800-12 63654080012 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-12) 2014-08-22 0000-00-00 No No Current 63654-800-20 63654080020 20 in 1 BLISTER PACK Historical