Sinus Headache PEMaximum Strength Non-Drowsy
- Product NDC
- 69168-270
- 11-digit product format
- 691680270
- Labeler code
- 69168
- Product ID
- 69168-270_5614edd7-fae9-4261-aa48-bd393f771caa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Phenylephrine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Allegiant Health
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-12-22
- Marketing end
- 2027-10-31
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- 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
- Sinus Headache PEMaximum Strength Non-Drowsy
- Brand name suffix
- Maximum Strength Non-Drowsy
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1046378 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f | 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 |
| 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 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69168-270-95 | 2020-03-13 | C162847 | 48780-1 | 9d75b9d0-f02b-f424-e053-dadaa90a57ce | Drug Facts |
| 69168-270-95 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f02b-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69168-270-95 | Sinus Headache PEMaximum Strength Non-DrowsyMaximum Strength Non-Drowsy | 18 in 1 BLISTER PACK | TABLET | 18 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69168-270 | SINUS HEADACHE PEMAXIMUM STRENGTH NON-DROWSY MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH] | 6 | Current NDC, Legacy NDC, 1 package rows | 20231114_b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f.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 |
|---|---|---|---|---|---|---|
| Acetaminophen | PAIN RELIEVER | McKesson | 9d620700-5d00-475f-e053-2995a90a9a3f | 2024-10-28 | Warnings | M013 |
| Junior Acetaminophen Ages 6-11 | ACETAMINOPHEN | Chain Drug Consortium | d356bc9c-66f1-45c3-a455-98c0b8890f78 | 2024-10-28 | Warnings | M013 |
| leader Acetaminophen | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 36bdcac9-eed4-40f9-a6f2-4c1e773a6b50 | 2024-10-25 | Warnings | M013 |
| GOODYS PM | ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE | Medtech Products Inc. | db5d6c2b-688e-4e88-a42d-0fa2b0d8140b | 2024-10-25 | Warnings | M013 |
| Goodys Extra Strength | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Medtech Products Inc. | 16d774cc-4247-4bf8-9b5a-c338ffebda3d | 2024-10-25 | Warnings | M013 |
| aspirin | ASPIRIN | PUBLIX SUPER MARKETS INC | 9e77ab7a-07e8-42aa-e053-2995a90a0d0e | 2024-10-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Kroger Company | 5bfd9841-c781-43be-b823-d334893ae6ed | 2024-10-24 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | H E B | add6952e-9dd5-487c-93e6-337e9d6a4872 | 2024-10-24 | Warnings | M013 |
| Dye Free Pain Reliever Childrens | ACETAMINOPHEN | Safeway, Inc. | 7d55cb42-295f-473a-941d-71825b44a3c0 | 2024-10-24 | Warnings | M013 |
| rapid release pain relief | ACETAMINOPHEN | Publix Super Markets Inc | d0b34133-d69d-47db-bf51-be942769c612 | 2024-10-24 | Warnings | M013 |
| basic care acetaminophen | ACETAMINOPHEN | Amazon.com Services LLC | 00146b91-008d-4b16-95b0-6077f98821be | 2024-10-24 | Warnings | M013 |
| equate pain reliever | ACETAMINOPHEN | WALMART INC. | 9a20273e-a4d1-4c38-9efb-e6347f8dc14e | 2024-10-24 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | MARC GLASSMAN, INC. | e221905b-a795-c067-e053-2a95a90a02e7 | 2024-10-23 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | MARC GLASSMAN, INC. | e221bbce-83de-0f03-e053-2995a90abca5 | 2024-10-23 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | MARC GLASSMAN, INC. | e231c2f6-927c-1ab0-e053-2995a90a6121 | 2024-10-23 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | MARC GLASSMAN, INC. | e23703bb-6087-7985-e053-2995a90aa5ec | 2024-10-23 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | MARC GLASSMAN, INC. | e237550d-711d-5d87-e053-2995a90affce | 2024-10-23 | Warnings | M013 |
| Aspirin | ASPIRIN | HARRIS TEETER | a6f15f71-1327-4b71-b9d6-e3e9f0243801 | 2024-10-22 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | HARRIS TEETER | 43308b23-7d4f-4e4f-a497-af71920d86aa | 2024-10-22 | Warnings | M013 |
| Pain Relief Regular Strength | ACETAMINOPHEN | MARC GLASSMAN, INC. | e21e821c-9694-5db0-e053-2995a90ad034 | 2024-10-22 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1046378 | acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f | 7 |
| 1046378 | acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f | 7 |
| 1046378 | APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69168-270-95 | 69168027095 | 18 TABLET in 1 BLISTER PACK (69168-270-95) | 18 tablet | 2014-12-22 | 2027-10-31 | No | No | Current |