Cold and Head Congestion Severe
- Product NDC
- 79481-3572
- 11-digit product format
- 794813572
- Labeler code
- 79481
- Product ID
- 79481-3572_fb078d01-5725-4bf7-85ae-b08d61ed4de5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Meijer Distribution, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-10
- 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
- Cold and Head Congestion Severe
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 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 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79481-3572-8 | Cold and Head Congestion Severe | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 3 | |
| 79481-3572-8 | Cold and Head Congestion Severe | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 79481-3572 | COLD AND HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION, INC.] | 2 | Current NDC, 2 package rows | 20240911_a41c62aa-90a4-4958-984f-b2fed0276c8a.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 |
|---|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | LEADER/ Cardinal Health 110, Inc. | e33cbd1d-1848-145a-e053-2995a90aeb50 | 2026-02-20 | Warnings | M012 |
| Head Congestion and Flu Severe Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 416080a9-e817-485b-a4ae-6c9d0152c165 | 2026-02-20 | Warnings | M012 |
| Walmart Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALMART STORES INC | 18436026-b0e4-4481-a647-d735a27d0b00 | 2026-02-19 | Warnings | M012 |
| Vaporizing | CAMPHOR | Meijer, Inc. | 7afc98d7-f64f-42d5-9022-28ad6b01db8a | 2026-02-19 | Warnings, Adverse reactions | M012 |
| CHILDRENS COLD AND COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Kroger Company | 8196b482-070e-4d7d-8943-129141f926ee | 2026-02-19 | Warnings | M012 |
| Walmart Dye Free Chidrens Allergy Chews Bubblegum | DIPHENHYDRAMINE HCL | WALMART STORES INC | 9f83d2f0-9718-4f2b-bc7f-e29ba2917412 | 2026-02-19 | Warnings | M012 |
| tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Kroger Company | be9aaf66-6c59-4042-88e2-acd920dcf992 | 2026-02-19 | Warnings | M012 |
| Allergy Relief Dye-Free | DIPHENHYDRAMINE HCL | CVS Pharmacy | 08459cf4-feb3-4283-88e1-d61e030c57f9 | 2026-02-19 | Warnings | M012 |
| allergy relief | CHLORPHENIRAMINE MALEATE | Rite Aid Corporation | b0d70488-ea1d-4c1d-bd07-53dfb0e4d03c | 2026-02-18 | Warnings | M012 |
| Walgreens Wild Cherry Pectin Throat Drops | PECTIN | Walgreens | 424fda2d-c1e5-0ed9-e063-6394a90a06ea | 2026-02-18 | Warnings | M012 |
| cough suppressant and topical analgesic | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Target Corporation | df21d9d6-36a9-49cf-a29c-c4a573899bd5 | 2026-02-18 | Warnings, Adverse reactions | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Amerisource Bergen | eeda80ff-212d-428e-a0c6-782f271357b4 | 2026-02-18 | Warnings | M012 |
| good sense night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L. Perrigo Company | e47dffdf-5778-4804-8ce2-54c5a72bba3a | 2026-02-18 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | United Natural Foods, Inc. dba UNFI | b139e7d6-bf4d-45b9-b7cf-d34e5352095c | 2026-02-17 | Warnings, Adverse reactions | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Strategic Sourcing Services LLC | bd54bf7a-2304-4c3f-9cd2-bafea217466e | 2026-02-17 | Warnings, Adverse reactions | M012 |
| Creomulsion For Children | DEXTROMETHORPHAN HYDROBROMIDE | Socius Care, LLC | 39d0e96c-1cc3-4961-e054-00144ff88e88 | 2026-02-17 | Warnings | M012 |
| Creomulsion Cough Medicine Adult Formula | DEXTROMETHORPHAN HYDROBROMIDE | Socius Care, LLC | 39d07486-99b7-5c06-e054-00144ff8d46c | 2026-02-17 | Warnings | M012 |
| Cold and Flu Severe, Day, Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR. GUAIFENESIN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 6e6bae79-1231-4b74-81c1-f0c914ed4af3 | 2026-02-17 | Warnings | M012 |
| COUGH AND CHEST CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dfe69c12-b5fe-46d1-a3bf-ef3729c2e786 | 2026-02-17 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 3fb49f64-2d77-44db-8186-5904837eedbe | 2026-02-17 | 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 | a41c62aa-90a4-4958-984f-b2fed0276c8a | 3 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | a41c62aa-90a4-4958-984f-b2fed0276c8a | 3 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | a41c62aa-90a4-4958-984f-b2fed0276c8a | 3 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | a41c62aa-90a4-4958-984f-b2fed0276c8a | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 79481-3572-8 | 79481357208 | 2 BLISTER PACK in 1 CARTON (79481-3572-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2024-09-10 | No | No | Current |