Home NDC 68016-127 Childrens Cold and Allergy
Product NDC 68016-127
11-digit product format 680160127
Labeler code 68016
Product ID 68016-127_93a3dbfa-0915-4bcc-8f69-a13be10690f5
Type HUMAN OTC DRUG
Nonproprietary name Brompheniramine maleate and Phenylephrine HCl
Dosage form SOLUTION
Route ORAL
Labeler Chain Drug Consortium, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-06-03
Marketing end 2022-04-01
Substance BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 1 mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68016-127-04 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68016-127-04 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68016-127-04 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68016-127-04 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68016-127-04 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68016-127-04 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68016-127-04 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68016-127-04 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68016-127-04 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68016-127-04 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68016-127-04 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68016-127-04 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BROMPHENIRAMINE MALEATE ACTIVE INGREDIENT IXA7C9ZN03 CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 BROMPHENIRAMINE ACTIVE MOIETY H57G17P2FN CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 GRAPE INACTIVE INGREDIENT 6X543N684K CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-127-04 68016012704 1 BOTTLE in 1 CARTON (68016-127-04) > 118 mL in 1 BOTTLE 1 bottle 2015-06-03 2022-04-01 No No Current