Tylenol Sinus Severe
- Product NDC
- 85237-1955
- Requested package NDC
- 85237-1955-3
- 11-digit product format
- 852371955
- Labeler code
- 85237
- Product ID
- 85237-1955_52c5c1df-46bc-f82a-e063-6294a90af6f0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Select Consumer Group LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-05-15
- Substance
- ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 200; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
- Tylenol Sinus Severe
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1243679 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 52c5fda0-c358-72e8-e063-6394a90a3f68 | 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 |
|---|---|---|---|---|---|---|
| DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED | Lil' Drug Store Products, Inc. | 37c55543-e05e-2f7c-e063-6394a90a4534 | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Honey Lemon Sugar-Free | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 38049d29-f47e-9478-e063-6294a90aa2a4 | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Menthol Sugar Free | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3804a271-9a11-848d-e063-6394a90af87d | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Menthol Sugar Free | MENTHOL | Army & Air Force Exchange Service | 3805ef07-247d-0df7-e063-6394a90ac45b | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drop Black Cherry Sugar Free | MENTHOL | Army & Air Force Exchange Service | 3805f8f5-562f-0ba8-e063-6394a90ac9d9 | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Honey Lemon Sugar-Free | MENTHOL | Army & Air Force Exchange Service | 3805f90e-bd89-128d-e063-6394a90afa01 | 2025-06-20 | Warnings | M012 |
| TARGET Multi Symptom Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | TARGET CORPORATION | aebe3c15-53ef-46ea-af39-8c9b8114595f | 2025-06-20 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Morning Star OTC | be95332d-a2e0-42e8-bfb3-8850d74990ff | 2025-06-19 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Morning Star OTC | 37e939c6-064b-3548-e063-6294a90a337d | 2025-06-19 | Warnings | M012 |
| Capron DM | DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE | Capital Pharmaceutical, LLC | cf778c5f-475e-4a86-a87c-2be1e665f5a5 | 2025-06-18 | Warnings | M012 |
| Cough Out | GUAIFENESIN | Efficient Laboratories Inc. | fe4c3921-8d30-4cd6-ba90-9211b362a38a | 2025-06-18 | Warnings | M012 |
| Guaifenesin STRAWBERRY-BANANA FLAVOR | GUAIFENESIN | Innovida Pharmaeutique Corporation | 1006906e-d6d7-4f49-92bf-3cb2d2cdbb16 | 2025-06-18 | Warnings | M012 |
| Mucinex Sinus Max Clear and Cool | ACETAMINOPHEN AND GUAIFENESIN | RB Health (US) LLC | 37de813a-54b7-672a-e063-6294a90a374e | 2025-06-18 | Warnings | M012 |
| childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4a1aeb41-a8fa-4116-8068-e11acd608e58 | 2025-06-18 | Warnings | M012 |
| NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIX | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED | Lil' Drug Store Products, Inc. | 37c768f5-dabd-22d0-e063-6394a90af9e5 | 2025-06-17 | Warnings | M012 |
| DISCOUNT DRUG MART Childrens Allergy Chewable | DIPHENHYDRAMINE HCL | DISCOUNT DRUG MART | 51de95da-e8e8-48f0-9fa4-6191aa4a247b | 2025-06-16 | Warnings | M012 |
| Halls Cherry | MENTHOL | Mondelez Global LLC | 5f4af8e8-8550-45c7-a199-694efac9e7be | 2025-06-16 | Warnings | M012 |
| Halls Honey Lemon | MENTHOL | Mondelez Global LLC | 25eaae85-d516-40da-a472-70736ea2b75d | 2025-06-16 | Warnings | M012 |
| Halls Cherry | MENTHOL | Mondelez Global LLC | bad89968-22a7-4287-a57c-9e6206e574fe | 2025-06-16 | Warnings | M012 |
| Herbal Throat Drops | LEMON MINT HERBAL | Meijer, Inc. | 37dd58ad-95d1-568c-e063-6394a90a9433 | 2025-06-16 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85237-1955-3 | 85237195503 | 20 POUCH in 1 CARTON (85237-1955-3) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) | 20 pouch | 2025-06-04 | No | No | Current |