Home NDC 28623-250-12 Cough and Cold
Product NDC 28623-250
Requested package NDC 28623-250-12
11-digit product format 286230250
Labeler code 28623
Product ID 28623-250_ee8a9ce6-4388-aaba-e053-2995a90a18a3
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Progela, S.A. de C.V.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-03-01
Marketing end 0000-00-00
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 250 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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 15 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…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 28623-250-01 Cough and ColdXL3 Xtra 20 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 20 5 28623-250-06 Cough and ColdXL3 Xtra 6 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 6 5 28623-250-12 Cough and ColdXL3 Xtra 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 5
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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, 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 [PROGELA, S.A. DE C.V.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 28623-250 COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PROGELA, S.A. DE C.V.] 5 Legacy NDC, 3 package rows 20221129_1d878c3c-dd0e-4024-ac98-7053748d164b.zip
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 28623-250-12 28623025012 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (28623-250-12) 2014-08-22 0000-00-00 No No Current