Tylenol
- Product NDC
- 50580-566
- 11-digit product format
- 505800566
- Labeler code
- 50580
- Product ID
- 50580-566_21aceda5-2c34-23df-e063-6394a90acb09
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-07-15
- 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
- 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
- Tylenol
- Brand name suffix
- Cold Plus Head Congestion Severe
- Listing expiration
- 2026-12-31
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 |
|---|---|
| ce43e5c2-fe96-4462-882c-d7479318b33d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-566-25 | TylenolCold Plus Head Congestion Severe | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 16 | |
| 50580-566-25 | TylenolCold Plus Head Congestion Severe | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-566 | TYLENOL COLD PLUS HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] | 16 | Current NDC, Legacy NDC, 2 package rows | 20241109_ce43e5c2-fe96-4462-882c-d7479318b33d.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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HCL | CVS Pharmacy | eafd9823-c0ad-454a-b725-562d88ebec92 | 2026-03-23 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4db0470b-1bf0-9137-e063-6394a90a1d54 | 2026-03-23 | Warnings | M012 |
| Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4db066d4-ddbe-ddce-e063-6394a90ac5f8 | 2026-03-23 | Warnings | M012 |
| Throat Comfort Orange Mint Cinnamon Drops | MENTHOL | Ricola Ag | 27487e5c-044c-41eb-865f-2f34351afd52 | 2026-03-23 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | f288eeca-9803-4962-a802-fe34f5983c7a | 2026-03-23 | Warnings | M012 |
| Throat Comfort Lemon Mint Ginger Drops | MENTHOL | Ricola Ag | d63b4d24-e926-418c-bb17-420aeaad5a62 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Congestion Cough Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 6e7dfee1-3de9-46c8-9b58-83fcf8ee72e0 | 2026-03-23 | Warnings | M012 |
| Maximum Strength Mucus Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | Hyvee Inc | 44eafc83-8e7b-89b8-e063-6394a90ab0bc | 2026-03-23 | Warnings | M012 |
| Throat Comfort Lemon Mint Ginger Drops | MENTHOL | Ricola USA Inc. | 5d7889b1-3866-49b0-97e1-1e883a52d3cb | 2026-03-23 | Warnings | M012 |
| Throat Comfort Orange Mint Cinnamon Drops | MENTHOL | Ricola USA Inc. | 1487652c-dbc1-40f4-9d59-891ec74cc363 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4e2a8b53-0074-42fd-8357-a39cc6afe608 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Severe Cold Daytime Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET Corporation | 5ccaf3b0-096a-4644-9c6e-9f251c167b3c | 2026-03-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4d88180f-610c-d9ab-e063-6394a90a09f0 | 2026-03-21 | Warnings | M012 |
| Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | HyVee Inc | cc371bc3-ba7a-430d-9ee4-22e9c50935f1 | 2026-03-20 | Warnings | M012 |
| Daytime Nighttime Multi Symptom Cold Childrens | DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreens | da4c36f5-ec79-4489-bb18-8ddab79c34bd | 2026-03-20 | Warnings | M012 |
| Sanatos Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Pharmadel LLC | 3bddcd5a-7776-49ff-e063-6294a90a5dd1 | 2026-03-20 | Warnings | M012 |
| Vaporizing | CAMPHOR | Amazon.com Services LLC | 21cfe9cb-5ff5-4331-8358-4d1d9646d6ac | 2026-03-19 | Warnings, Adverse reactions | M012 |
| Equate Wild Cherry Throat Drop | PECTIN | Walmart | 4d66547a-b72a-a0ac-e063-6394a90adc71 | 2026-03-19 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Safeway, Inc. | 45d44cd2-5187-4a5c-983a-edb1e8eba0b2 | 2026-03-19 | Warnings | M012 |
| Sedalmex XL Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Belmora LLC | f2edfedf-e06e-4d1b-8c2d-732e08ec113c | 2026-03-19 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | ce43e5c2-fe96-4462-882c-d7479318b33d | 16 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | ce43e5c2-fe96-4462-882c-d7479318b33d | 16 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | ce43e5c2-fe96-4462-882c-d7479318b33d | 16 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | ce43e5c2-fe96-4462-882c-d7479318b33d | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-566-25 | 50580056625 | 2 BLISTER PACK in 1 CARTON (50580-566-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2013-07-15 | 0000-00-00 | No | No | Current |