Home NDC 53345-012-01 DayTime Sinus Relief
Product NDC 53345-012
Requested package NDC 53345-012-01
11-digit product format 533450012
Labeler code 53345
Product ID 53345-012_27c747b1-6757-989b-e063-6394a90a124b
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, phenylephrine hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-06-15
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 5 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 DayTime Sinus Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D 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 1052670 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 53345-012-01 DayTime Sinus Relief 4000 in 1 BAG CAPSULE, LIQUID FILLED 4000 3 53345-012-01 DayTime Sinus Relief 1 in 1 BOX CAPSULE, LIQUID FILLED 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53345-012 DAYTIME SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 3 Current NDC, Legacy NDC, 2 package rows 20241127_4361912e-4b56-4743-b11d-acfb94482a2e.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 53345-012-01 53345001201 1 BAG in 1 BOX (53345-012-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2013-06-15 0000-00-00 No No Current