Home NDC 50844-112 Nasal Decongestant
Product NDC 50844-112
11-digit product format 508440112
Labeler code 50844
Product ID 50844-112_478a22dd-e80a-44c4-abb3-ec361d945afd
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 1981-08-25
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Nasal Decongestant
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50844-112-08 Nasal Decongestant 12 in 1 BLISTER PACK TABLET, FILM COATED 12 19 50844-112-08 Nasal Decongestant 2 in 1 CARTON TABLET, FILM COATED 2 19 50844-112-22 Nasal Decongestant 12 in 1 BLISTER PACK TABLET, FILM COATED 12 19 50844-112-22 Nasal Decongestant 4 in 1 CARTON TABLET, FILM COATED 4 19 50844-112-46 Nasal Decongestant 8 in 1 CARTON TABLET, FILM COATED 8 19 50844-112-46 Nasal Decongestant 12 in 1 BLISTER PACK TABLET, FILM COATED 12 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-112 NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 17 Current NDC, Legacy NDC, 6 package rows 20240816_f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc5.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 179 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mucus Relief DM MUCUS RELIEF DM TopCo Associates, LLC 71674a9b-89ed-43d1-aadb-b9311fdfbdf9 2022-06-07 Warnings Exact identifier application number: M012 Daytime Nighttime Cold and Flu Relief Combo Pack DAYTIME NIGHTTIME COLD AND FLU Allegiant Health fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 2022-05-19 Warnings Exact identifier application number: M012 Mucus Relief DM Immediate Release MUCUS RELIEF DM Good Sense 26a199bf-57e5-4f36-b40c-83a1187e4870 2022-05-18 Warnings Exact identifier application number: M012 Mucus Relief DM Immediate Release MUCUS RELIEF DM Allegiant Health 731f8608-ad5b-491e-a4d4-2bb0c423fed5 2022-05-18 Warnings Exact identifier application number: M012 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL OPMX LLC b3c229a4-c772-70fb-e053-2a95a90a72db 2022-03-11 Warnings Exact identifier application number: M012 Allergy Relief CHLORPHENIRAMINE MALEATE Good Sense f88e2654-8e97-4cf6-9c36-01aeb51a9102 2021-11-30 Warnings Exact identifier application number: M012 Cold Medicine COLD MEDICINE Allegiant Health 443fbc44-2c33-4316-ad31-dcc5a5aa8f52 2021-11-23 Warnings Exact identifier application number: M012 Decongestant PE Non Drowsy PHENYLEPHRINE HCL Allegiant Health 7a3098b4-381c-4f32-97a7-87b53fd64428 2021-06-16 Warnings Exact identifier application number: M012 Mucus Relief Immediate Release GUAIFENESIN 400MG Good Sense e7c68746-7ec0-46cf-b4a3-174fab819b5e 2021-05-05 Warnings Exact identifier application number: M012 Mucus Relief Immediate Release GUAIFENESIN 400MG TopCo Associates, LLC 7d91c6ab-d161-42b9-b353-0aa8f59619f8 2021-01-21 Warnings Exact identifier application number: M012 Daytime Cold and Flu ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG Allegiant Health bed5f9dc-45ea-4e90-86c6-86599b6f3861 2020-11-16 Warnings Exact identifier application number: M012 Nighttime Cold and Flu Relief ACETAMINOPHEN Allegiant Health b97126d7-847d-483e-b3d1-e2b61ab1743f 2020-11-11 Warnings Exact identifier application number: M012 Cold and Allergy PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE Allegiant Health 7af63769-fa56-4f1f-a2ad-5b4c108c8e4f 2019-12-12 Warnings Exact identifier application number: M012 Mucus Relief Immediate Release GUAIFENESIN Allegiant Health 221d64a2-b8c7-435a-aae4-fb58fd38108f 2019-03-26 Warnings Exact identifier application number: M012 Sleep Tabs For Nighttime use DIPHENHYDRAMINE HCL TABLETS Allegiant Health 566e40b1-e9d7-44e4-b971-eef2b7cf0a7d 2018-12-26 Warnings Exact identifier application number: M012 Allergy CHLORPHENIRAMINE MALEATE Allegiant Health 4305ad50-d2a5-4d3e-9d92-cbf26e856a16 2018-12-26 Warnings Exact identifier application number: M012 Sleep Aid DIPHENHYDRAMINE HCL 25 MG Allegiant Health dbbc535f-515a-4d9b-b799-34e60f5230bb 2018-12-21 Warnings Exact identifier application number: M012 Allergy DIPHENHYDRAMINE HCL Allegiant Health c2823bad-540f-4662-8dcc-58e9f0d94efb 2018-11-07 Warnings Exact identifier application number: M012 Nasal Decongestant PE Maximum Strength Non-Drowsy PHENYLEPHRINE 10 MG Allegiant Health 7aef00df-816a-4ea2-a2ad-beed66dd2fe4 2018-11-07 Warnings Exact identifier application number: M012 DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE Westminster Pharmaceuticals, LLC a58bfb14-28f9-4425-a5a5-aaff4847c979 2018-03-14 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 50844-112-08 50844011208 2 BLISTER PACK in 1 CARTON (50844-112-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 1981-08-25 0000-00-00 No No Current 50844-112-22 50844011222 4 BLISTER PACK in 1 CARTON (50844-112-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK 4 blister pack 1981-08-25 0000-00-00 No No Current 50844-112-46 50844011246 8 BLISTER PACK in 1 CARTON (50844-112-46) / 12 TABLET, FILM COATED in 1 BLISTER PACK 8 blister pack 1981-08-25 0000-00-00 No No Current