NightTime Sinus
- Product NDC
- 53345-031
- Requested package NDC
- 53345-031-01
- 11-digit product format
- 533450031
- Labeler code
- 53345
- Product ID
- 53345-031_27c7e81e-6413-2983-e063-6394a90a722b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-02-26
- Substance
- ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 6.25; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [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
- NightTime Sinus
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1052647 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0f3b1404-9252-470a-aa8c-b360c85731f3 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53345-031-01 | NightTime Sinus | 4000 in 1 BAG | CAPSULE, LIQUID FILLED | 4000 | 3 | |
| 53345-031-01 | NightTime Sinus | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53345-031 | NIGHTTIME SINUS (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241127_0f3b1404-9252-470a-aa8c-b360c85731f3.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | 87ebb4d9-78d7-1c87-e053-2a95a90adb7d | 2025-03-27 | Warnings | M012 |
| REVASOL CHILDRENS ALLERGY | DIPHENHYDRAMINE HCL | Rnv LLC | 3143137f-ef42-5358-e063-6394a90a8ed1 | 2025-03-26 | Warnings | M012 |
| Rompe Pecho SF FLU | DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Efficient Laboratories Inc | bc10695a-9664-4ce3-82bb-820da06129fa | 2025-03-26 | Warnings | M012 |
| SUPRESS-PE Pediatric | GUIAFENESIN, PHENYLEPHRINE HCL | Kramer Novis | a474171d-5c29-4a80-9d37-00613796211a | 2025-03-26 | Warnings | M012 |
| Guaifenesin DM | DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN | Innovida Pharmaeutique Corporation | dd3f806b-2470-4055-94e1-18adac811025 | 2025-03-25 | Warnings | M012 |
| Foster and Thrive childrens cold cough relief dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Strategic Sourcing Services LLC | 38b710e3-1d01-4ff4-a6b6-44936f277f49 | 2025-03-25 | Warnings | M012 |
| Revasol Tussin DM Max with Honey | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Rnv LLC | 30da9255-c93a-84d6-e063-6394a90a7c2a | 2025-03-21 | Warnings | M012 |
| REVASOL NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Rnv LLC | 30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9 | 2025-03-21 | Warnings | M012 |
| Chest Congestion Relief | GUAIFENESIN | Meijer, Inc. | 261a79b3-5704-76f2-e063-6394a90a5ac6 | 2025-03-20 | Warnings | M012 |
| Rompe Tos X Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05cc932d-b412-0710-e063-6394a90a87f6 | 2025-03-19 | Warnings | M012 |
| Rompe Tos X Adults | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05abb2db-d22e-90b5-e063-6294a90ace3f | 2025-03-19 | Warnings | M012 |
| Sinus Head Congestion | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 30a07773-bd6f-b9f2-e063-6394a90ab8aa | 2025-03-18 | Warnings | M012 |
| Halls Sugar Free Black Cherry | MENTHOL | Mondelez Global LLC | bd2a311a-bf0c-4365-af9b-76675c243b22 | 2025-03-16 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | TARGET CORPORATION | fbca9627-5e12-048a-e053-6294a90a6e0f | 2025-03-15 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | DOLGENCORP, INC. | 0655688e-7c42-507f-e063-6294a90ae498 | 2025-03-15 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY, INC | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 2025-03-14 | Warnings | M012 |
| Ultra Concentrated Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300b2357-933b-fe9a-e063-6294a90aa4b9 | 2025-03-11 | Warnings | M012 |
| Ultra Concentrated Nighttime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | PuraCap Pharmaceutical LLC | 300bf27f-744f-7366-e063-6394a90acbcb | 2025-03-11 | Warnings | M012 |
| Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300c7c7b-ea0b-3650-e063-6294a90a65e8 | 2025-03-11 | Warnings | M012 |
| Rompe Pecho Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | EFFICIENT LABORATORIES INC | 2ec319a8-92bf-4552-86dd-37cbce18980f | 2025-03-11 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1052647 | acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 0f3b1404-9252-470a-aa8c-b360c85731f3 | 3 |
| 1052647 | acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 0f3b1404-9252-470a-aa8c-b360c85731f3 | 3 |
| 1052647 | APAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 0f3b1404-9252-470a-aa8c-b360c85731f3 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-031-01 | 53345003101 | 1 BAG in 1 BOX (53345-031-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2015-02-26 | 0000-00-00 | No | No | Current |