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 |
|---|---|---|---|---|---|---|
| Pain Relief | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1c083e29-8732-4ecd-ab4b-9038acbd0b9d | 2025-05-22 | Warnings | M013 |
| TYLENOL For Children Plus Adults | ACETAMINOPHEN | Kenvue Brands LLC | 5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42 | 2025-05-21 | Warnings | M013 |
| Children Acetaminophen | ACETAMINOPHEN | AARNA USA INC. | 25bcb9d5-f388-4ae7-8037-970ffe8d17f0 | 2025-05-16 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | HF Acquisition Co LLC, DBA HealthFirst | 35478de8-50d0-5d0a-e063-6294a90a88ba | 2025-05-16 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 95f4b628-6d35-4f6b-91f9-b2d117f8e821 | 2025-05-16 | Warnings | M013 |
| good neighbor pharmacy childrens pain and fever | ACETAMINOPHEN | Amerisource Bergen | 268a789b-8f31-4739-9777-523249cac326 | 2025-05-13 | Warnings | M013 |
| ASPIRIN LOW DOSE | ASPIRIN LOW DOSE | AARNA USA INC. | 347edc8f-6391-b75e-e063-6394a90a1cf5 | 2025-05-06 | Warnings | M013 |
| Good Neighbor Pharmacy Infants Pain and Fever | ACETAMINOPHEN | Amerisource Bergen | 2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb2 | 2025-05-06 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | AARNA USA INC. | 34157f6a-3031-4388-e063-6394a90a670f | 2025-05-01 | Warnings | M013 |
| ASPIRIN | ASPIRIN | HF Acquisition Co LLC, DBA HealthFirst | 2553d0cb-3f5c-7ea0-e063-6294a90a3cd4 | 2025-05-01 | Warnings, Adverse reactions | M013 |
| Aspirin 81mg Enteric Coated | ASPIRIN | Advanced Rx LLC | 606067bb-b07f-444e-9465-d1e187735f3a | 2025-05-01 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | AARNA USA INC. | 33f0e822-28af-9bb2-e063-6294a90a5175 | 2025-04-29 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 27fcca07-f845-77fe-e063-6394a90aa2f8 | 2025-04-24 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 46a6bbb9-ccd1-47a8-9e58-485f71f57063 | 2025-04-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 061c91d5-5aa8-4556-a344-197b7e8a10b8 | 2025-04-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | c4f0f591-8501-4c6d-bf8e-ca3068ff65b5 | 2025-04-24 | Warnings | M013 |
| Extra Strength No-Pain | ACETAMINOPHEN | Safrel Pharmaceuticals, LLC. | 873f01dd-0701-5fd3-e053-2a95a90a6463 | 2025-04-23 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Chain Drug Consortium | 60d4b392-6ed0-4115-8154-24eaf72504a5 | 2025-04-16 | Warnings | M013 |
| Premsyn pms Premenstrual Pain Relief | ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE | Focus Consumer Healthcare, LLC | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 2025-04-14 | Warnings | M013 |
| BackAid Max | ACETAMINOPHEN, PAMABROM | Kobayashi Healthcare International, Inc. | fb9a5647-b7c9-4820-b148-91060e34cb83 | 2025-04-14 | 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 |