Home NDC 63868-144 Nasal Decongestant PE
Product NDC 63868-144
11-digit product format 638680144
Labeler code 63868
Product ID 63868-144_d534021e-9167-4966-bd79-d13ee792282b
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CHAIN DRUG MARKETING ASSOCIATION INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-01-14
Marketing end 2027-11-30
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 PE
Brand name suffix Non-Drowsy Maximum Strength Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1049182 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-144-19 Nasal Decongestant PENon-Drowsy Maximum Strength 1 in 1 CARTON TABLET, FILM COATED 1 18 63868-144-19 Nasal Decongestant PENon-Drowsy Maximum Strength 18 in 1 BLISTER PACK TABLET, FILM COATED 18 18 63868-144-37 Nasal Decongestant PENon-Drowsy Maximum Strength 2 in 1 CARTON TABLET, FILM COATED 2 18 63868-144-37 Nasal Decongestant PENon-Drowsy Maximum Strength 18 in 1 BLISTER PACK TABLET, FILM COATED 18 18 63868-144-74 Nasal Decongestant PENon-Drowsy Maximum Strength 18 in 1 BLISTER PACK TABLET, FILM COATED 18 18 63868-144-74 Nasal Decongestant PENon-Drowsy Maximum Strength 4 in 1 CARTON TABLET, FILM COATED 4 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 4 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 4 DEXTROSE MONOHYDRATE INACTIVE INGREDIENT LX22YL083G NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 4 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-144 NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 17 Current NDC, Legacy NDC, 6 package rows 20250130_bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d.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 71 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Honey Lemon cough drops MENTHOL Walmart Stores Inc. 317bbd33-6087-3af1-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Good Sense Nasal Decongestant PSEUDOEPHEDRINE HCL L. Perrigo Company 455b35b4-3969-411b-8036-887615d71e11 2025-12-21 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Safeway Inc. 4a4f7f82-1b6c-7082-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Safeway Inc. 4a52c0c2-8659-2819-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Cherry Cough Drops MENTHOL Safeway a733e905-af15-d3ea-e053-2a95a90aa7c3 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Honey Lemon Cough Drops MENTHOL Safeway a742449f-c76b-2b91-e053-2a95a90ae4d2 2025-12-20 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE TopCo 60b876e7-c642-5ce8-e053-2a91aa0abd6e 2025-12-20 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Topco Associates 366cc6b1-beff-29d2-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL TopCo Associates 3fef2117-7311-1e66-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Topco Associates 3ff1bf05-e407-3b67-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL Topco Associates 36727f0c-d6d2-28a3-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL Topco Associates 36824bee-607e-7095-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Mixed Berry Sore Throat Lozenges BENZOCAINE Topco Associates 7a00c771-9231-e877-e053-2a91aa0ac96e 2025-12-20 Warnings Exact identifier application number: M012 MUCUS RELIEF GUAIFENESIN 400 MG NUVICARE LLC e25b440e-f389-443f-b333-c66ad1747158 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu severe ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL Wal-Mart Stores Inc 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Geiss, Destin & Dunn Inc. a7d2eaee-484e-43aa-8ae3-0e050219383f 2025-12-19 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Publix 66d8e5f7-9766-57f3-e053-2991aa0a7e17 2025-12-19 Warnings Exact identifier application number: M012 Honey Lemon Cough Drops MENTHOL Publix 66e89fa3-ee09-1d16-e053-2a91aa0ae17c 2025-12-19 Warnings Exact identifier application number: M012 Poly-Vent DM DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL Poly Pharmaceuticals, Inc. 739329ae-0b62-4eab-a07d-867b5d3d61e0 2025-12-19 Warnings Exact identifier application number: M012 Chest Congestion and Cough Relief DM DEXTROMETHORPHAN HBR, GUAIFENESIN ARMY AND AIR FORCE EXCHANGE SERVICE 89494a7c-cdbf-48f1-aaa9-2e57d4388a68 2025-12-19 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 63868-144-19 63868014419 1 BLISTER PACK in 1 CARTON (63868-144-19) / 18 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2005-01-14 2027-07-31 No No Current 63868-144-37 63868014437 2 BLISTER PACK in 1 CARTON (63868-144-37) / 18 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-01-14 2027-11-30 No No Current 63868-144-74 63868014474 4 BLISTER PACK in 1 CARTON (63868-144-74) > 18 TABLET, FILM COATED in 1 BLISTER PACK 4 blister pack 2005-01-14 2022-03-23 No No Current