equaline daytime cold and flu relief
- Product NDC
- 41163-656
- 11-digit product format
- 411630656
- Labeler code
- 41163
- Product ID
- 41163-656_9fde32a9-1123-412e-9da4-b4dfed492a25
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- United Natural Foods, Inc. dba UNFI
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-10-12
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [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
- 2027-12-31
- 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 | 41163-656 | 41163-656-34 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 41163-656 | 41163-656-38 | D | Discontinued by firm | 2026-10-20 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41163-656-34 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41163-656-38 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41163-656-34 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41163-656-38 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41163-656-34 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41163-656-38 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41163-656-34 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41163-656-38 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41163-656-34 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41163-656-38 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41163-656-34 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41163-656-38 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41163-656-34 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41163-656-38 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41163-656-34 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41163-656-38 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41163-656-34 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41163-656-38 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41163-656-34 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41163-656-38 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41163-656-34 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41163-656-38 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 41163-656-38 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 41163-656-34 | 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
- equaline daytime cold and flu relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1113705 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9a199782-5d7e-449b-a86c-969746f0e96f | 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 |
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 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 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 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 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | 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 |
|---|---|---|---|---|---|---|
| 41163-656-34 | equaline daytime cold and flu relief | 237 mL in 1 BOTTLE | SOLUTION | 237 | 11 | |
| 41163-656-38 | equaline daytime cold and flu relief | 296 mL in 1 BOTTLE | SOLUTION | 296 | 11 | |
| 41163-656-40 | equaline daytime cold and flu relief | 355 mL in 1 BOTTLE | SOLUTION | 355 | 11 | |
| 41163-656-40 | equaline daytime and nighttime cold and flu relief | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 10 mg in 15mL | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 41163-656-38 | ML - Milliliter | 41163-656 | b6f6eb80-2153-4845-b6b5-abd236921308 | 1 | 2013-02-13 |
| 41163-656-40 | ML - Milliliter | 41163-656 | 7e4c619a-75ac-46bf-ae44-80a010bc5102 | 1 | 2016-11-08 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41163-656 | EQUALINE DAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [UNITED NATURAL FOODS, INC. DBA UNFI] | 10 | Current NDC, Legacy NDC, 3 package rows | 20240927_9a199782-5d7e-449b-a86c-969746f0e96f.zip |
| 41163-656 | EQUALINE DAYTIME AND NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [UNITED NATURAL FOODS, INC. DBA UNFI] | 9 | Current NDC, Legacy NDC | 20241116_8fc2389c-9657-4dbe-a32b-df8245fc67ca.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 |
|---|---|---|---|---|---|---|
| Halls Sugar Free Cherry | MENTHOL | Mondelez Global LLC | ea8dfe96-f6a4-4172-bf9e-ae3cf606ff50 | 2025-02-14 | Warnings | M012 |
| Halls Sugar Free Watermelon | MENTHOL | Mondelez Global LLC | c4c090ca-f083-74e0-e053-2a95a90a9d60 | 2025-02-14 | Warnings | M012 |
| Tukol Max Action | OXYMETAZOLINE HYDROCHLORIDE | Genomma Lab USA | 73358103-43dc-4b11-9c89-9a6ba45bf1af | 2025-02-14 | Warnings | M012 |
| Maximum Strength Mucus Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Chain Drug Marketing Association Inc. | 6c4e867b-24b9-4525-9fab-10f1e7910b13 | 2025-02-13 | Warnings | M012 |
| DAYTIME- NIGHTTIME COLD AND FLU | DAYTIME NIGHTTIME COLD AND FLU | TARGET CORP | 9def204a-ee1e-6868-e053-2995a90a76b8 | 2025-02-13 | Warnings | M012 |
| Daytime Cold and Flu and Nigttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | f2c11b63-278f-64de-e053-2995a90a5aae | 2025-02-12 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | BETTER LIVING BRANDS LLC. | f29c604a-271d-a702-e053-2a95a90a3427 | 2025-02-12 | Warnings | M012 |
| Nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | f2c01090-645c-1efe-e053-2995a90a7df5 | 2025-02-12 | Warnings | M012 |
| AXIV DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 131b1f17-cd86-f9b3-e063-6294a90a3028 | 2025-02-12 | Warnings | M012 |
| Maximum Strength Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Topco Associates, LLC | 17d0dbc7-c8c2-7917-e063-6394a90a42af | 2025-02-12 | Warnings | M012 |
| DAYTIME COLD AND FLU | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Kroger Company | bc00bbf8-52bb-fa75-e053-2a95a90a9406 | 2025-02-11 | Warnings | M012 |
| Daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELS | TIME CAP LABORATORIES, INC. | fd24653e-c4fa-3c09-e053-6394a90aaa9e | 2025-02-10 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELS | TIME CAP LABORATORIES INC. | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2025-02-10 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | DOLGENCORP, LLC | be2207b7-b8f8-7fba-e053-2a95a90abd16 | 2025-02-10 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE | Kroger Company | bc0115a3-5322-855d-e053-2995a90aba27 | 2025-02-10 | Warnings | M012 |
| Day time high blood pressure cold and flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR | Camber Consumer Care | 09fbd872-0970-4864-9308-4a7b85983920 | 2025-02-10 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f05e11ce-c908-acbc-e053-2a95a90a584e | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f035c499-cda6-fadf-e053-2995a90af457 | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f6d977ce-bbca-f1cc-e053-6394a90acc96 | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f6da36d3-496d-2336-e053-6394a90a0f83 | 2025-02-09 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 9a199782-5d7e-449b-a86c-969746f0e96f | 11 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 9a199782-5d7e-449b-a86c-969746f0e96f | 11 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 9a199782-5d7e-449b-a86c-969746f0e96f | 11 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 9a199782-5d7e-449b-a86c-969746f0e96f | 11 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 9a199782-5d7e-449b-a86c-969746f0e96f | 11 |
| 2637726 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } Pack | GPCK | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) Pack | PSN | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) Pack | SY | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41163-656-34 | 41163065634 | 237 mL in 1 BOTTLE (41163-656-34) | 237 ml | 2014-07-28 | 0000-00-00 | No | No | Current |
| 41163-656-38 | 41163065638 | 296 mL in 1 BOTTLE (41163-656-38) | 296 ml | 2011-10-12 | 0000-00-00 | No | No | Current |
| 41163-656-40 | 41163065640 | 355 mL in 1 BOTTLE (41163-656-40) | 355 ml | 2012-07-11 | 0000-00-00 | No | No | Current |