Maximum Strength Nighttime Severe Cold and Flu
- Product NDC
- 68210-4210
- 11-digit product format
- 682104210
- Labeler code
- 68210
- Product ID
- 68210-4210_34c5c0c9-71c9-9151-e063-6294a90a0f44
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Prodose, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-08-19
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68210-4210-1 | E | Excluded after deficient or non-compliant submission was not corrected | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68210-4210-1 | E | Excluded after deficient or non-compliant submission was not corrected | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68210-4210-1 | E | Excluded after deficient or non-compliant submission was not corrected | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68210-4210-1 | E | Excluded after deficient or non-compliant submission was not corrected | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68210-4210-1 | E | Excluded after deficient or non-compliant submission was not corrected | cdf11ea48f46… | ba0047e9e063… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68210-4210-1 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68210-4210-1 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68210-4210-1 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Maximum Strength Nighttime Severe Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1297288 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c3d0b70f-d213-4e38-88ab-1c89d93a391d | Available on FDA.report |
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 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 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 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 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 |
|---|---|---|---|---|---|---|
| 68210-4210-1 | Maximum Strength Nighttime Severe Cold and Flu | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 11 | |
| 68210-4210-1 | Maximum Strength Nighttime Severe Cold and Flu | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 11 |
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 |
|---|---|---|---|---|---|---|
| Pocket Farmacy | MENTHOL | Saje Natural Business Inc. | bdc15c6f-73b4-488e-9134-e70565df71bb | 2026-01-14 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCL 50 MG | DIPHENHYDRAMINE HCL | YYBA Corporation | 4b012549-3958-43c1-9de7-897c5d8b20d3 | 2026-01-14 | Warnings | M012 |
| Rite Aid Pharmacy congestion relief vaporizing steam | VAPORIZING STEAM | Rite Aid Pharmacy | 0fb86b23-0313-8fd8-e063-6394a90a0f5f | 2026-01-14 | Warnings | M012 |
| Vapo Steam | VAPO STEAM | TOPCO ASSOCIATES, LLC | f216f69f-9580-25ac-e053-2995a90a5ac6 | 2026-01-14 | Warnings | M012 |
| Leader Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Cardinal Health 110, LLC. dba Leader | f27bf0b2-25cc-474c-ab6b-f227ed3525fa | 2026-01-14 | Warnings | M012 |
| Sinus PE plus Allergy | CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | Walgreen Company | a15979d4-87bf-42e7-b1f2-783496072141 | 2026-01-13 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | 41f4bf6d-f83c-92e4-e063-6394a90aebab | 2026-01-13 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 3e608643-1a74-b474-e063-6294a90ad2e0 | 2026-01-13 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 462cbf3d-51b1-dab9-e063-6394a90a70ba | 2026-01-13 | Warnings | M012 |
| Pocket Farmacy | MENTHOL | Saje Natural Business Inc. | 4260542e-0980-4b0b-8177-1c9f2c53b5a6 | 2026-01-13 | Warnings | M012 |
| Sweet Comfort | MENTHOL | Saje Natural Business Inc. | cf13cccd-723d-4d61-8a5e-b36281605cc7 | 2026-01-13 | Warnings | M012 |
| Fortify | MENTHOL | Saje Natural Business Inc. | 0320a305-99d1-4909-94cc-cd6509ecb948 | 2026-01-13 | Warnings | M012 |
| Rolling Farmacy | MENTHOL | Saje Natural Business Inc. | a38765a9-22cd-4fc5-b5ab-c3cacbd52c74 | 2026-01-13 | Warnings | M012 |
| Home Farmacy | MENTHOL | Saje Natural Business Inc. | add35d10-b27a-4ae8-b2de-8a285aaef155 | 2026-01-13 | Warnings | M012 |
| Traveling Farmacy | MENTHOL | Saje Natural Business Inc. | 5b70f5aa-ed36-65ab-e053-2a91aa0a6777 | 2026-01-13 | Warnings | M012 |
| sinus plus allergy PE maximum strength | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 660d3c80-f249-41dd-aa93-a0b1e635ead0 | 2026-01-13 | Warnings | M012 |
| Chest Comfort | MENTHOL | Saje Natural Business Inc. | 8a3db169-6dd7-4dfd-8360-90315288f21b | 2026-01-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | H E B | c9e977b6-fba6-49ea-9d80-b43b0842bbe1 | 2026-01-12 | Warnings | M012 |
| PE Sinus Congestion | PHENYLEPHRINE HCL | Topco Associates, LLC | 3264e291-7a0f-4e25-8390-ba441f22f650 | 2026-01-12 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | CVS PHARMACY | 3f44cff6-240a-4a8d-aaa1-0da75a31a47b | 2026-01-12 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | c3d0b70f-d213-4e38-88ab-1c89d93a391d | 11 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | c3d0b70f-d213-4e38-88ab-1c89d93a391d | 11 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | c3d0b70f-d213-4e38-88ab-1c89d93a391d | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68210-4210-1 | 68210421001 | 1 BLISTER PACK in 1 CARTON (68210-4210-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2022-08-19 | 0000-00-00 | No | No | Current |