Home NDC 12830-754-30 M-END
Product NDC 12830-754
Requested package NDC 12830-754-30
11-digit product format 128300754
Labeler code 12830
Product ID 12830-754_efea1788-442f-8396-e053-2995a90a5cc4
Type HUMAN OTC DRUG
Nonproprietary name Codeine Phosphate, Phenylephrine Hydrochloride, Brompheniramine Maleate
Dosage form LIQUID
Route ORAL
Labeler R.A. McNeil Company
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2008-11-11
Marketing end 0000-00-00
Substance BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 1 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], alpha-1 Adrenergic Agonist [EPC]
DEA schedule CV
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 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BROMPHENIRAMINE MALEATE ACTIVE INGREDIENT IXA7C9ZN03 M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 BROMPHENIRAMINE ACTIVE MOIETY H57G17P2FN M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2 WATER INACTIVE INGREDIENT 059QF0KO0R M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 12830-754-30 12830075430 30 mL in 1 BOTTLE (12830-754-30) 30 ml 2014-12-19 0000-00-00 No No Current