Home NDC 69729-222-27 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Product NDC 69729-222
Requested package NDC 69729-222-27
11-digit product format 697290222
Labeler code 69729
Product ID 69729-222_b3c20bae-91cc-dc02-e053-2995a90aaad8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Dosage form TABLET
Route ORAL
Labeler OPMX LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2019-08-26
Marketing end 0000-00-00
Substance PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Active strength 10 mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2021-12-31
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 · 12 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 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 69729-222-06 2025-01-30 Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-222-27 2025-01-30 Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-222-37 2025-01-30 Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-222-38 2025-01-30 Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-222-27 2023-09-04 Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-222-37 2023-09-04 Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-222-38 2023-09-04 Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-222-27 2022-01-28 Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-222-37 2022-01-28 Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-222-38 2022-01-28 Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69729-222-06 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 2 in 1 POUCH TABLET 2 3 69729-222-06 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 3 in 1 CARTON TABLET 3 3 69729-222-27 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 2 in 1 POUCH TABLET 2 3 69729-222-37 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 12 in 1 POUCH TABLET 12 3 69729-222-38 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 144 in 1 POUCH TABLET 144 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-222 ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL TABLET [OPMX LLC] 3 Legacy NDC, 5 package rows 20230905_b3c2158c-6ee1-dba9-e053-2995a90a8555.zip
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 69729-222-27 69729022227 2 TABLET in 1 POUCH (69729-222-27) 2 tablet 2019-08-26 0000-00-00 No No Current