NDC 85534-0046-07 - Butalbital, Acetaminophen, Caffeine
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 85534-0046
- Requested NDC
- 85534-0046-07
- Package NDCs from labels
- 85534-0046-0, 85534-0046-1, 85534-0046-2, 85534-0046-3, 85534-0046-4, 85534-0046-5, 85534-0046-6, 85534-0046-7, 85534-0046-8, 85534-0046-07
- Manufacturer
- HAWAII REPACK, INC.
- Effective date
- 2026-07-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg | HAWAII REPACK, INC. | 2026-07-17 | HUMAN PRESCRIPTION DRUG LABEL |
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 |
|---|---|---|---|---|---|---|
| Walgreen Childrens COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 801880b2-6116-4d26-a7bf-a669eef6ad8b | 2025-11-26 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Asclemed USA, Inc. | cce09e09-158f-4927-8a3e-4ec9334f0b7a | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | ANDA209587 238154 3G6A5W338E KHS0AZ4JVK 362O9ITL9D |
| Pain Reliever, 24/7 Life by 7-Eleven | ACETAMINOPHEN TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 44828b89-2563-b233-e063-6294a90ab124 | 2025-11-26 | Warnings | 362O9ITL9D |
| Bambusa Pulsatilla | BAMBUSA PULSATILLA | Uriel Pharmacy Inc. | 0776c3be-088d-422c-9c12-08fcaae823e1 | 2025-11-26 | Warnings | ETJ7Z6XBU4 |
| MEMBERS MARK ACETAMINOPHEN | ACETAMINOPHEN | Sam's West Inc | 03e831d4-8060-4633-9d02-e77100063fb4 | 2025-11-26 | Warnings | 362O9ITL9D |
| Childrens Pain and Fever Dissolve Packs | ACETAMINOPHEN | WALGREENS CO. | ea0f265f-7d64-4731-beda-0bb841dd1ad7 | 2025-11-25 | Warnings | 362O9ITL9D |
| Nighttime Wal Flu Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | WALGREEN CO. | e88f7777-9987-4e3c-a3d5-3da60f190bfd | 2025-11-25 | Warnings | 362O9ITL9D |
| Multi Symptom Wal Flu Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | WALGREEN CO. | 9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb | 2025-11-25 | Warnings | 362O9ITL9D |
| WALGREEN Daytime Multi Symptom Flu Relief Max Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | WALGREENS CO. | c92a0f47-0b7c-4034-83d1-b7d2ed8022fc | 2025-11-25 | Warnings | 362O9ITL9D |
| Walgreen NightTime Cold and Flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | WALGREENS CO. | 6b3766e6-d0d4-49e0-90da-fc893aef3329 | 2025-11-25 | Warnings | 362O9ITL9D |
| Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | WALGREENS CO | 807e8ace-2901-4c5f-96dc-04c755484b95 | 2025-11-25 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | American Health Packaging | 79bb61d7-8836-4ce7-91bc-9463efbad9cf | 2025-11-25 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Theraflu Flu Relief Max Strength Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 2025-11-25 | Warnings | 362O9ITL9D |
| Thyroid-Adrenal | ADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEA | Newton Laboratories, Inc. | b597504a-c667-225c-e053-2a95a90ac704 | 2025-11-25 | Warnings | ETJ7Z6XBU4 |
| DOCTRUST ONE S Tooth | SODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATE | DONG IL PHARMS CO.,LTD | 4476923a-48f1-9f72-e063-6394a90a0708 | 2025-11-25 | Warnings | ETJ7Z6XBU4 |
| DOCTRUST K Tooth | SILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATE | DONG IL PHARMS CO.,LTD | 44768dd1-b132-c33b-e063-6294a90accd4 | 2025-11-25 | Warnings | ETJ7Z6XBU4 |
| Gout Pain Management | ARNICA MONTANA, URTICA URENS, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAF | Forces of Nature | 9276fe9c-d9a2-4cef-986c-5d7d39f2d6a1 | 2025-11-25 | Warnings | ETJ7Z6XBU4 |
| day time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | eaf3af6a-de5b-43fe-83ff-9641646e0f6b | 2025-11-25 | Warnings | 362O9ITL9D |
| Natural Eyes Floaters Relief | CHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEA | TRP Company | 445dc831-195e-4b25-e063-6294a90a6efd | 2025-11-24 | Warnings | ETJ7Z6XBU4 |
| Basic Care Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | e19b561c-fb76-4355-a306-d3dc46930bf2 | 2025-11-24 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.