PANADOL
- Product NDC
- 0135-0608
- 11-digit product format
- 001350608
- Labeler code
- 0135
- Product ID
- 0135-0608_10c16df6-aa2f-03c3-e063-6294a90a93e5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen and diphenhydramine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-12-01
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 500; 25 mg/1; mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PANADOL
- Brand name suffix
- PM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, TC2D6JAD40 |
| Rxcui | 1092189, 1094718 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-0608-01 | PANADOLPM | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | | 7 |
| 0135-0608-01 | PANADOLPM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 7 |
| 0135-0608-02 | PANADOLPM | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 7 |
| 0135-0608-02 | PANADOLPM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 7 |
| 0135-0608-03 | PANADOLPM | 50 in 1 CARTON | TABLET, FILM COATED | 50 | | 7 |
| 0135-0608-04 | PANADOLPM | 2 in 1 PACKET | TABLET, FILM COATED | 2 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0608 | PANADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HALEON US HOLDINGS LLC] | 7 | Current NDC, Legacy NDC, 6 package rows | 20240207_01e7dddb-755c-4745-b701-edcdb6209064.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0135-0608-01 | 00135060801 | 1 BOTTLE in 1 CARTON (0135-0608-01) / 24 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2016-12-01 | 0000-00-00 | No | No | Current |
| 0135-0608-02 | 00135060802 | 1 BOTTLE in 1 CARTON (0135-0608-02) / 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2016-12-01 | 0000-00-00 | No | No | Current |
| 0135-0608-03 | 00135060803 | 50 PACKET in 1 CARTON (0135-0608-03) / 2 TABLET, FILM COATED in 1 PACKET (0135-0608-04) | 50 packet | 2016-12-01 | 0000-00-00 | No | No | Current |
| 0135-0608-04 | 00135060804 | 2 in 1 PACKET | | | | | | Historical |