Home NDC 69729-322 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Product NDC 69729-322
11-digit product format 697290322
Labeler code 69729
Product ID 69729-322_d9f8d76e-5f7a-fb3c-e053-2995a90a3125
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Dosage form TABLET
Route ORAL
Labeler OPMX LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-26
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 500; 4; 10 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 · 56 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 CHLORPHENIRAMINE MALEATE 4 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup V1Q0O9OJ9Z Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2463332 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 69729-322-27 2025-03-18 Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-322-37 2025-03-18 Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-322-38 2025-03-18 Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-322-27 2022-01-28 Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-322-37 2022-01-28 Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) 69729-322-38 2022-01-28 Resfriol D (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 69729-322-27 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 2 in 1 POUCH TABLET 2 2 69729-322-37 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 12 in 1 POUCH TABLET 12 2 69729-322-38 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 144 in 1 POUCH TABLET 144 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-322 ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL TABLET [OPMX LLC] 2 Current NDC, Legacy NDC, 3 package rows 20250321_b3c229a4-c772-70fb-e053-2a95a90a72db.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 80 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join cherry throat relief lozenges BENZOCAINE Cintas Corporation 49b25e9e-1d47-4a10-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 cherry sore throat lozenge BENZOCAINE CVS Pharmacy 3c54974d-9d15-2fa1-e054-00144ff88e88 2025-12-07 Warnings Exact identifier application number: M012 honey lemon sore throat lozenges BENZOCAINE CVS Pharmacy 3c55009c-4b3e-135e-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL CVS Pharmacy 3bdd24a8-3b44-00cd-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL CVS Pharmacy 3c125b3a-e58f-5c06-e054-00144ff88e88 2025-12-07 Warnings Exact identifier application number: M012 CVS Menthol Cough Drops MENTHOL CVS Pharmacy de97d13b-bb67-d0e6-e053-2995a90aeb2c 2025-12-07 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL American Sales 34dd34d1-1a08-3470-e054-00144ff8d46c 2025-12-06 Warnings Exact identifier application number: M012 DOLOGEN ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE Kramer Novis 656ea9ba-c9cf-44c6-af40-b8ba292ce38a 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Severe Congestion OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC a79b5541-864b-412a-a085-96986ed6af59 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Extra Moisturizing OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. 346f32cb-74cb-4896-b770-76d5f829a17d 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Original Pump Mist OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. 530b2d27-5883-489e-87fa-90b45eb93b3c 2025-12-05 Warnings Exact identifier application number: M012 Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE Bayer HealthCare LLC. ee666963-e686-4374-b52b-a677f1cd4114 2025-12-05 Warnings Exact identifier application number: M012 Afrin No-Drip Allergy Sinus OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC 3beb5839-7422-449d-e054-00144ff88e88 2025-12-05 Warnings Exact identifier application number: M012 Coricidin HBP Nighttime Multi-Symptom Cold ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE Bayer HealthCare LLC. 513ca24f-1262-4a2d-e054-00144ff8d46c 2025-12-05 Warnings Exact identifier application number: M012 Afrin Severe Congestion OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. a49a506e-aca2-4af0-a50b-dca2c031e61d 2025-12-05 Warnings Exact identifier application number: M012 Throat Coat Sweet Orange Fennel MENTHOL Traditional Medicinals, Inc. a746cef4-1fb4-45cf-e053-2995a90a02c8 2025-12-05 Warnings Exact identifier application number: M012 Guaifenesin GUAIFENESIN Health Pharma USA LLC 31755594-3e1c-b290-e063-6394a90aba61 2025-12-05 Warnings Exact identifier application number: M012 Tabcin Extra Strength ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, Pharmadel LLC 0670c33e-8a3c-ae00-e063-6294a90a165b 2025-12-05 Warnings Exact identifier application number: M012 Severe Sinus Congestion and Pain ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE Shield Pharmaceuticals Corp d0dd4a75-da65-4c66-b65f-54ee14100846 2025-12-05 Warnings Exact identifier application number: M012 Basic Care Cherry Cough Drops MENTHOL Amazon.com c0588221-0c84-66d8-e053-2995a90a874f 2025-12-05 Warnings Exact identifier application number: M012
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 69729-322-27 69729032227 2 TABLET in 1 POUCH (69729-322-27) 2 tablet 2019-08-26 0000-00-00 No No Current 69729-322-37 69729032237 12 TABLET in 1 POUCH (69729-322-37) 12 tablet 2019-08-26 0000-00-00 No No Current 69729-322-38 69729032238 144 TABLET in 1 POUCH (69729-322-38) 144 tablet 2019-08-26 0000-00-00 No No Current