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 98 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Menthol Drops Dollar General Severe Honey Lemon 45ct MENTHOL Dollar General Corporation 0ea61a4c-690a-4349-9952-cc17fb1f0671 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Dollar General Menthol 30ct MENTHOL Dollar General Corporation 892092cc-5a1c-4309-baf9-a040888d3577 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Dollar General Menthol 80ct MENTHOL Dollar General Corporation 773f4ad2-6c91-431f-ad3d-c0e53e7ca918 2025-10-08 Warnings Exact identifier application number: M012 Menthol Drops Dollar General Severe 45ct MENTHOL Dollar General Corporation 13c7d3b1-12ac-4931-877c-728d3d89942c 2025-10-08 Warnings Exact identifier application number: M012 Menthol Drops Dollar General Severe Honey Lemon 45ct MENTHOL Dollar General Corporation d0c878f0-a737-4583-9847-834af70e7d6f 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Freegells Strawberry 30ct MENTHOL R.L. ALBERT & SON, INC dc077c36-c403-4b83-894a-e9922e928841 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Freegells Strawberry 30ct MENTHOL RL Albert & Son Inc. 2ea760f3-df50-4c46-a43d-d5ed07f421a5 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Honey Lemon 200ct MENTHOL RL Albert & Son Inc. 3ac08274-08d9-4dab-b09a-6e297948a25a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Honey Lemon 30ct MENTHOL RL Albert & Son Inc. 8114e1a2-728d-4489-a494-f28a5e7d9bb3 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 30ct MENTHOL RL Albert & Son Inc. 0c2e594a-cdf8-4595-bda6-0ebc19ac3850 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 200ct MENTHOL R.L. ALBERT & SON, INC f62b7f75-3275-46c9-880c-64148d0dce59 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 80ct MENTHOL R.L. ALBERT & SON, INC 15917bfb-f660-4a12-bdcc-5b4a96e0e1d0 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL RL Albert & Son Inc. 92c54c53-c8bb-4576-abae-715a2f3878bf 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 80ct MENTHOL RL Albert & Son Inc. c96cc162-5908-4990-9dc1-3ce912844274 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL R.L. ALBERT & SON, INC bac77712-6197-4b30-a5f8-9b99eb9d7b5a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL R.L. ALBERT & SON, INC 6842d766-ade6-40b2-831b-f4feac25c6db 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL RL Albert & Son Inc. 9f324ca1-0e2a-47e3-997e-2aaa68a85751 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 30ct MENTHOL R.L. ALBERT & SON, INC 2063a013-aa0b-465d-b04f-cfe2e70d749f 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 200ct MENTHOL R.L. ALBERT & SON, INC cd81488c-74d8-48d9-9c73-ff662a5cd4cd 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 80ct MENTHOL R.L. ALBERT & SON, INC 61deea94-d0a9-4563-926b-53f255a7c425 2025-10-08 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