Neo-Synephrine Severe
- Product NDC
- 0225-0811
- 11-digit product format
- 002250811
- Labeler code
- 0225
- Product ID
- 0225-0811_54edb0ef-b9fc-8470-e063-6394a90a5885
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- BF ASCHER AND CO INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-01
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 1 g/100mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 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
- Neo-Synephrine Severe
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 1 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 54edaff7-d241-dc90-e063-6294a90ac64d | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 2023-10-10 | Warnings | M012 |
| Triacting Daytime Cold Cough Childrens | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8656aa2e-9546-4de4-9ecc-ce99bf903333 | 2023-10-10 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL | Walgreens | a33ae35b-1cde-4a3d-a836-3b169e4f1bb9 | 2023-10-10 | Warnings | M012 |
| Severe Cold and Cough Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 553d01a9-e8ad-4797-b55b-32f134f08af9 | 2023-10-10 | Warnings | M012 |
| Mucus Relief Maximum StrengthCold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 8781e2c5-ad46-4615-a0d9-879590e86f95 | 2023-10-10 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 419df833-1f33-45cf-bab3-730c928d5887 | 2023-10-10 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 93a5cb36-3262-4224-a5be-5ea1619a67bd | 2023-10-10 | Warnings | M012 |
| Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN | CVS Pharmacy | 782fb103-cd9f-4e8c-8f3a-1fb131b9eda6 | 2023-10-09 | Warnings | M012 |
| Cold and Congestion Childrens Nighttime | DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL | Walgreens | a7847413-e556-4f88-8a7f-a8528afbe927 | 2023-10-09 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | 06d2c6cf-0adb-91b9-e063-6294a90aff52 | 2023-10-03 | Warnings | M012 |
| NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Lil' Drug Store Products, Inc. | e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b | 2023-10-02 | Warnings | M012 |
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | PD-Rx Pharmaceuticals, Inc. | ac8c0c15-b305-47f2-8712-e4b53636f7fa | 2023-10-02 | Warnings | M012 |
| Maximum strength Day cold and flu and Night severe cold and flu | ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS | TIME CAP LABORATORIES,INC | fff69901-965c-5372-e053-6394a90a29c2 | 2023-09-18 | Warnings | M012 |
| Tussin Mucus and Chest Congestion Sugar Free | GUAIFENESIN | AARNA USA, Inc. | 6e488782-0138-436d-a9f0-0ec5bc9daedd | 2023-05-15 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | KROGER COMPANY | 813b1db2-a177-77c6-e053-2a91aa0ac73b | 2023-01-17 | Warnings | M012 |
| MUCUS RELIEF DM | DEXTROMETHORPHAN HBR/GUAIFENESIN | KROGER COMPANY | 813baf42-edb0-33a9-e053-2a91aa0a8599 | 2023-01-17 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H-E-B | db19b8c7-0334-0664-e053-2a95a90ad61f | 2023-01-14 | Warnings | M012 |
| Nightime | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | H-E-B | db44560b-da02-74c9-e053-2a95a90af0b6 | 2023-01-13 | Warnings | M012 |
| DAYTIME COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | dbf5656b-9105-871b-e053-2995a90a4941 | 2023-01-03 | Warnings | M012 |
| DAYTIME-NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | KROGER | a2508699-08c0-4a22-e053-2a95a90a8a6d | 2022-11-02 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0225-0811-47 | 00225081147 | 15 mL in 1 BOTTLE, SPRAY (0225-0811-47) | 15 ml | 2026-06-01 | No | No | Current |