Theraflu Flu Relief Max Strength
- Product NDC
- 0067-7923
- 11-digit product format
- 000677923
- Labeler code
- 0067
- Product ID
- 0067-7923_357ca5d8-877d-8cce-e063-6294a90a5cae
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, and Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
- Dosage form
- KIT
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-06-15
- 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
- Theraflu Flu Relief Max Strength
- Brand name suffix
- Daytime Nighttime Combo Pack
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 812a093f-cf83-4f7a-927a-1b5695be7f90 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-7921-02 | Theraflu Flu Relief Max StrengthDaytime Nighttime Combo Pack | 6 in 1 CARTON | POWDER | 6 | 30 mg | 5 |
| 0067-7922-02 | Theraflu Flu Relief Max StrengthDaytime Nighttime Combo Pack | 6 in 1 CARTON | POWDER | 6 | 4 mg | 5 |
| 0067-7923-02 | Theraflu Flu Relief Max StrengthDaytime Nighttime Combo Pack | 1 in 1 CARTON | KIT | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-7923 | THERAFLU FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20250521_812a093f-cf83-4f7a-927a-1b5695be7f90.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 |
|---|---|---|---|---|---|---|
| Freegells Cough Drops Menthol Honey Lemon | MENTHOL | Riclan S.A. | f6271e85-9ca2-41d3-9bff-a13670ac5b80 | 2023-10-26 | Warnings | M012 |
| Freegells Cough Drops Menthol Strawberry | MENTHOL | Riclan S.A. | da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457 | 2023-10-26 | Warnings | M012 |
| DG Health Cough Drops Assorted Flavors | MENTHOL | Dollar General Corporation | c731d255-40f2-3cb3-e053-2a95a90a8877 | 2023-10-26 | Warnings | M012 |
| ALKA SELTZER PLUS Cold Day and Night Effervescent | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Sincronia Logistica, S.A. de C.V. | c478df69-823a-4112-8f44-323249a9f38f | 2023-10-23 | Warnings | M012 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | P & L Development, LLC | 169006cb-7dc2-4113-a289-0b1f14e784b7 | 2023-10-23 | Warnings | M012 |
| Night-Time Cold and Flu Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | HealthLife of USA | 2ffd62a6-703f-4cb0-bb13-49719c004d00 | 2023-10-21 | Warnings | M012 |
| Day-Time Cold and Flu Relief | ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN | HealthLife of USA | c5f6cf22-2aaa-40e1-b7b3-448e55898d62 | 2023-10-21 | Warnings | M012 |
| PENTREXCILINA | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Healthlife of USA | ae9ada14-0ec8-4c01-a874-237f2108936a | 2023-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | APNAR PHARMA LP | e5004c10-3877-c199-e053-2a95a90aa8ac | 2023-10-21 | Boxed warning, Warnings | M012 |
| Day and Night Multi Symptom Cold and Flu Relief | DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF | Intrivo Diagnostics Inc. | a311bf39-de6c-4ed5-949e-718ad8be1e49 | 2023-10-13 | Warnings | M012 |
| Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 2023-10-10 | Warnings | M012 |
| Triacting Daytime Cold Cough Childrens | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8656aa2e-9546-4de4-9ecc-ce99bf903333 | 2023-10-10 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL | Walgreens | a33ae35b-1cde-4a3d-a836-3b169e4f1bb9 | 2023-10-10 | Warnings | M012 |
| Severe Cold and Cough Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 553d01a9-e8ad-4797-b55b-32f134f08af9 | 2023-10-10 | Warnings | M012 |
| Mucus Relief Maximum StrengthCold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 8781e2c5-ad46-4615-a0d9-879590e86f95 | 2023-10-10 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 419df833-1f33-45cf-bab3-730c928d5887 | 2023-10-10 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 93a5cb36-3262-4224-a5be-5ea1619a67bd | 2023-10-10 | Warnings | M012 |
| Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN | CVS Pharmacy | 782fb103-cd9f-4e8c-8f3a-1fb131b9eda6 | 2023-10-09 | Warnings | M012 |
| Cold and Congestion Childrens Nighttime | DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL | Walgreens | a7847413-e556-4f88-8a7f-a8528afbe927 | 2023-10-09 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | 06d2c6cf-0adb-91b9-e063-6294a90aff52 | 2023-10-03 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2636659 | {1 (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } Pack | GPCK | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 5 |
| 2636659 | {1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } Pack | PSN | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 5 |
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Powder for Oral Solution | PSN | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 5 |
| 2636656 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | PSN | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 5 |
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SCD | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 5 |
| 2636656 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SCD | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 5 |
| 2636659 | {1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) } Pack | SY | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 5 |
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution | SY | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 5 |
| 2636656 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution | SY | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 5 |
| 2636658 | APAP 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SY | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 5 |
| 2636656 | APAP 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SY | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0067-7921-02 | 00067792102 | 6 in 1 CARTON | Historical | |||||
| 0067-7922-02 | 00067792202 | 6 in 1 CARTON | Historical | |||||
| 0067-7923-02 | 00067792302 | 1 KIT in 1 CARTON (0067-7923-02) * 6 POWDER in 1 CARTON (0067-7921-02) * 6 POWDER in 1 CARTON (0067-7922-02) | 1 kit | 2022-06-15 | 0000-00-00 | No | No | Current |