Allergy plus Sinus Headache
- Product NDC
- 83059-0045
- 11-digit product format
- 830590045
- Labeler code
- 83059
- Product ID
- 83059-0045_4276cd88-1e1e-408b-e063-6394a90ae904
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen 325 mg, Diphenhydramine HCl 12.5 mg, Phenylephrine HCl 5 mg
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Shield Pharmaceuticals Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-02
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 12.5; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Allergy plus Sinus Headache
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, TC2D6JAD40, 04JA59TNSJ |
| Rxcui | 1233575 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83059-0045-1 | Allergy plus Sinus Headache | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 4 |
| 83059-0045-1 | Allergy plus Sinus Headache | 1 in 1 PACKAGE | TABLET, FILM COATED | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83059-0045 | ALLERGY PLUS SINUS HEADACHE (ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG) TABLET, FILM COATED [SHIELD PHARMACEUTICALS CORP] | 3 | Current NDC, 2 package rows | 20241228_ea74e6a0-ff0f-44dc-8fdc-54c4a860c1a8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83059-0045-1 | 83059004501 | 1 BOTTLE in 1 PACKAGE (83059-0045-1) / 15 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-09-02 | No | No | Current |