dg health night time cold and flu relief
- Product NDC
- 55910-335
- 11-digit product format
- 559100335
- Labeler code
- 55910
- Product ID
- 55910-335_cdb5731b-c7b5-4412-a438-d67466827bbd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Dolgencorp Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-08-17
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 55910-335 | 55910-335-38 | D | Discontinued by firm | 2026-10-27 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 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
- dg health night time cold and flu relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043400 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 55910-335-34 | 2023-08-07 | Dolgencorp, LLC Night Time Cold & Flu Relief Drug Facts |
| 55910-335-38 | 2023-08-07 | Dolgencorp, LLC Night Time Cold & Flu Relief Drug Facts |
| 55910-335-40 | 2023-08-07 | Dolgencorp, LLC Night Time Cold & Flu Relief Drug Facts |
| 55910-335-34 | 2023-07-28 | Dolgencorp, LLC Night Time Cold & Flu Relief Drug Facts |
| 55910-335-38 | 2023-07-28 | Dolgencorp, LLC Night Time Cold & Flu Relief Drug Facts |
| 55910-335-40 | 2023-07-28 | Dolgencorp, LLC Night Time Cold & Flu Relief Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55910-335-34 | dg health night time cold and flu relief | 237 mL in 1 BOTTLE | SOLUTION | 237 | 11 | |
| 55910-335-38 | dg health night time cold and flu relief | 296 mL in 1 BOTTLE | SOLUTION | 296 | 11 | |
| 55910-335-40 | dg health night time cold and flu relief | 355 mL in 1 BOTTLE | SOLUTION | 355 | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55910-335 | DG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC] | 10 | Current NDC, Legacy NDC, 3 package rows | 20241027_dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1.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 |
|---|---|---|---|---|---|---|
| SUDAFED PE Head Congestion Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 1e528f78-0ced-4a06-935a-84056c921727 | 2024-11-08 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 657a1e59-104c-4152-b2c9-00a8b82dc78e | 2024-11-08 | Warnings | M012 |
| Tylenol Cold plus Flu Severe and Tylenol Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 47c61858-72ce-409b-a3af-a63620cf7d13 | 2024-11-08 | Warnings | M012 |
| Childrens Benadryl Allergy Plus Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | b8b75904-3806-4258-89c1-d6ff486ed41c | 2024-11-08 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 464de5de-0e7a-41d6-875f-dd0e5fe7893c | 2024-11-08 | Warnings | M012 |
| McKesson Phenylephrine HCl | PHENYLEPHRINE HCL | McKesson Medical-Surgical | e09060f7-ca0b-5f7c-e053-2995a90ab344 | 2024-11-08 | Warnings | M012 |
| daytime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | e0e216ef-300c-4f57-87e6-62a5327e09b4 | 2024-11-08 | Warnings | M012 |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 969c0718-ba6e-4edb-9f55-43bc9500450f | 2024-11-08 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | 62a70d9a-4e78-497c-8f75-012ab94e92f6 | 2024-11-08 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Publix Super Markets Inc | 25b2ad8a-5835-4496-815f-73a7fb40dcfd | 2024-11-08 | Warnings | M012 |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Rite Aid Corporation | 296f20c0-8b5f-4a08-9329-f93c92e63867 | 2024-11-08 | Warnings | M012 |
| topcare tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Topco Associates LLC | d3cae69e-41a5-4099-a3f4-ce25fd94df73 | 2024-11-08 | Warnings | M012 |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 9d147d1e-8ea5-4e0f-8ae8-1da16f119496 | 2024-11-08 | Warnings | M012 |
| equate adult cough and chest congestion dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | WALMART INC. | e770bdb2-3662-4538-8199-fe4a4059c720 | 2024-11-08 | Warnings | M012 |
| DG Health Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | 23dcb627-c867-435f-9d1a-a9f49e58b58f | 2024-11-08 | Warnings | M012 |
| good neighbor pharmacy adult tussin DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amerisource Bergen | ced71993-f535-4e28-bc1d-3fcb7d86e9b7 | 2024-11-08 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS Pharmacy | 2f1dc8f8-79c5-4724-99aa-a55330ed9d5f | 2024-11-08 | Warnings | M012 |
| good sense day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 4ac6b64a-8214-4b03-8aa5-0d3199cf0b72 | 2024-11-08 | Warnings | M012 |
| tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | H E B | 1dd9afb6-9b58-4274-a557-900a0cb23524 | 2024-11-08 | Warnings | M012 |
| DG health sinus severe | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | 7abaa912-be8b-463c-8818-104e79b33539 | 2024-11-07 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1 | 11 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1 | 11 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1 | 11 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1 | 11 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55910-335-34 | 55910033534 | 237 mL in 1 BOTTLE (55910-335-34) | 237 ml | 2019-06-11 | 0000-00-00 | No | No | Current |
| 55910-335-38 | 55910033538 | 296 mL in 1 BOTTLE | 296 ml | Historical | ||||
| 55910-335-40 | 55910033540 | 355 mL in 1 BOTTLE (55910-335-40) | 355 ml | 2015-05-06 | 0000-00-00 | No | No | Current |